About

The MedDev Day keeps the discussion going!
Enrol in the online event to take place in 21st – 24th September 2021!
A 4-day event to discuss ongoing hot topics in the world of Medical Devices (MDs), In-Vitro Diagnostics (IVDs) and Software Medical Devices (SaMD).

The regulations are already tough – and getting tougher. The MDR and the IVDR place more emphasis on a life-cycle approach to safety, backed up by clinical performance data. Both regulations present stringent requirements for Notified Bodies, control and monitoring by competent authorities. Within this context, staying up to date with the latest news and discussions in the global medical device industry is a complex task.

The MedDev Day, organized by LS Academy has reached its third edition, and will once again serve as a central meeting place for the medical technology industry, bringing together lecture forums, interviews, workshops and networking opportunities. The event will be 360-degree overview of the evolving context of medical devices, in-vitro-diagnostics and software.
Hot topics in discussion will include:

  • Strategic approach to the claims in the clinical evaluation and MDR requirements
  • RWD & RWE in clinical evaluations
  • Benchmarking clinical data for better study designs
  • How to implement Post-Market Surveillance processes following MDR art. 88
  • IVDR and technical documentation
  • Regulatory management of medical devices under the MDR
  • Cybersecurity of medical devices
  • Scientific validation of algorithms

«Over the past 10 years, the medical device industry has been growing on average 4.2% per annum in the European medical device market. (…) Medical technology is characterized by a constant flow of innovations, which are the results of a high level of research and development within the industry, and of close cooperation with the users (1).»

Scientific Board
Francesco Dell'Antonio - Vice President, Regulatory Affairs and Quality Assurance at Quanta System
Laura Michellini -Scientific Director at Contract Research Organizations Latis Srl and Elle Research Srl
Sascha Wettmarshausen - Head of Regulatory Affairs at VDGH e.V. (German IVD-Association)
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

Laura C Collada Ali - MedDev Day Scientific Coordinator, LS Academy

Who should attend?
The event is designed for professionals in the field of Medical Devices, devoted to departments such as:

  • Clinical Operations
  • Product Managers
  • Regulatory Affairs
  • Quality Assurance/Control
  • Risk Management
  • Medical Device Engineering
  • Device vigilance
  • R&D
  • Medical Affairs
  • Medical Writring

from Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organizations.

(1)MedTech Europe. The European Medical Technology Industry in figures 2020.
Available here: https://www.medtecheurope.org/wp-content/uploads/2020/05/The-European-Medical-Technology-Industry-in-figures-2020.pdf
Programme

5 sessions to choose from based on your interests:
SESSION 1 | General: Medical Devices Clinical Evaluation & Clinical Investigation
SESSION 2 | General: Post-market Surveillance
SESSION 3: In-Vitro Diagnostics
SESSION 4: Regulatory Management
SESSION 5: Software Medical Devices

Complete programme available soon
Morning sessions: from 10:00 AM to 12:30 PM CEST
Afternoon sessions: from 2:00 PM to 4:30 PM CEST

21 September 2021
Morning CEST
SESSION 1 | General: Medical Devices Clinical Evaluation & Clinical Investigation
To claim or Not to Claim - Practical Considerations on How to Approach Claims within the Clinical Evaluation of a Medical Device
Silvia Casagrande - Clinical Evidence Manager at Orthofix SRL

The clinical evaluation process allows a manufacturer of a medical device to evaluate if there is sufficient clinical evidence to declare compliance with safety, performance and benefit / risk ratio essential requirements. Within this process the claims made by the manufacturer are a fundamental input that should be taken into consideration at a very early stage, namely during planning and scoping of the clinical evaluation. Indeed, the claims made embody the foundations for the entire process.
The aim of this session is not only to discuss the controversy under the definition of “claim”, but also to provide practical considerations and best practices on how to analyze and find correct sources to substantiate claims. In particular, we will discuss:

  • The different types of claims
  • The importance of claims in the clinical evaluation process
  • Sources for substantiation of claims: clinical data and more
  • The re-evaluation of claims in the post market phase
  • Considerations for legacy medical devices transitioning to MDR
Benchmarking Clinical Data for Medical Devices to improve your Study Design
Jasminka Roth - Founder and Director of The Tao of Excellence

Putting a medical device on the market is widely seen as a linear process with two separate stages, that of pre and post-market. These tend to be independently managed, and although they rely one another they are unlikely to know each other’s regulatory requirements or the ways that they could collaborate to help a product to thrive on the market. The observational data of real-world evidence (RWE) has not traditionally been a focus for pre-market clinical teams. Now however, the EU’s medical device regulation (MDR) and in vitro diagnostic medical device regulation (IVDR) radically reinforces the regulatory requirements for clinical trials for pre and post-marketing, citing these as vital to ensuring the safety and performance of a product on the market.

New technology now enables us to review, analyse and utilise clinical data from real-world applications for regulatory purposes, health tech assessments and more. We can design clinical trials with the RWE manuscript in mind and in turn use RWE to influence new clinical trials that can support the lifecycle of a product on the market.

Whilst this talk will define the framework of these new regulatory requirements, it will also highlight the fact that RWE can now be used and shared to support the regulatory requirements for a device.

What are the Consequences of the ISO14155 update on Clinical Investigations set-up?
Maurizio Cuocolo - Head of Quality Management Unit at OPIS Srl

This presentation will focus on the new changes introduced by the ISO 14155:2020 update, and the relation these have with the new requirements of the MDR 2017/745 Section VI (articles 61-82 + Annex XV). The aim will be to provide a practical approach to clinical investigation management, addressing the need of all stakeholders involved.

Among the changes introduced by the last edition of ISO 14155:2020 we note:

  • the inclusion of a summary section of GCP principles
  • reference to registration of clinical investigation in a publicly accessible database
  • inclusion of clinical quality management
  • inclusion of risk-based monitoring
  • inclusion of statistical considerations
  • inclusion of guidance for ethics committees
  • reinforcement of risk management throughout the process of a clinical investigation (from planning to results)
  • clarification of applicability of the requirements of this ISO to the different clinical development stages
  • inclusion of guidance on clinical investigation audits.

Furthermore, practical aspects of clinical investigation set up will be discussed, as well as specific considerations of risk management of clinical investigations, the set-up of specific plans for clinical investigation managements as well as the critical aspects checked during audits and inspections.

Clinical Evaluation Reviews under MDR – Notified Body Experience since Designation
Itoro Udofia - MHS-UK Director at TÜV SÜD

This presentation will look to provide the early experience and some insights (from a notified body point of view) on the clinical evaluation assessments carried out under the new medical device regulations.

  • How have NBs conducted assessments under the MDR (compared to MDD).
  • What difficulties have been encountered in the assessment of manufacturer’s technical documentation. There will be some emphasis on the review of the CER and PMCF.
Afternoon CEST
SESSION 2 | General: Post-Market Surveillance
PMS Expectations of Notified Bodies under the EU MDR 2017/745
Bassil Akra - CEO at QUNIQUE Group

The medical device regulation was published in May 2017 with a transition period of 3 years. Due to COVID19 Pandemic, the date of application of the regulation was postponed to May 2021 instead of May 2020. This delay gave manufacturers and other related stakeholders additional time to prepare their system for the MDR and to close ongoing projects under the directives MDD and AIMDD. According to the MDR transitional provisions listed in Article 120, any medical device manufacturer planning to place devices on the market from 26 of May 2021 must comply with the post-market surveillance of the EU MDR. This obligation applies also to directive devices making use of the grace period.

During this presentation, we will present the expectations of notified bodies and when relevant surveillance authorities and share some helpful guidance towards compliance with the new requirements.

Attendees of this session will learn about feasible methodologies to comply with the active post-market surveillance requirements throughout the entire lifetime of the device.

PMCF under the MDR: the Latest Insights
Wiebe Postma - Sr Consultant & CRO Lead at Qserve CRO

The EU Medical Device Regulations reinforce the rules on clinical evidence and post market surveillance for medical devices. Manufacturers are required to perform Post Market Clinical Follow-up (PMCF) as a continuous process that updates the clinical evaluations of their devices with new clinical data. A wide range of PMCF activities can be used to collect this data including clinical investigations, registries, surveys and literature reviews. The PMCF methods vary in the type and quality of clinical evidence that can be collected.

In this presentation we will review the PMCF requirements and, based on recent experience with PMCF planning, data collection and notified body acceptance, we will give insights in how to identify and address clinical data gaps using appropriate PMCF methods. Lastly, the role of PMCF in life cycle management will be discussed.

IMDRF Adverse Event Coding Implementation in Clinical Evaluation and PMS Documentation: A Case Study
Kelly Goodwin Burri - Senior Clinical Evaluation Specialist at Stryker

The harmonized terminology and coding system for adverse event reporting for medical devices established by the IMDRF enables the use of a standardized language across quality management system processes.

How have device manufacturers integrated these codes into existing QMS processes? And how can companies ensure optimal alignment across all teams using the coding system?

This case study will showcase best practices and lessons learned from the implementation of IMDRF coding (Annexes A, E, and F) in the clinical evaluation process and how these processes were aligned cross-functionally with complaint reporting, post-market surveillance, and risk management teams.

Interaction between Post-market Surveillance, Clinical Data, Clinical Evaluation and Risk Management
Jan Bart Hak - Head Medical Device Department at ProPharma Group

During this interview we will discuss the interactions between post market surveillance, clinical evaluation and risk management regarding clinical data.

The Medical Device Regulation intensifies the focus on clinical data that is necessary to fulfill the general safety and performance requirements. Where the MDD spent 2 pages on the topic, the regulation has 60 pages on clinical evidence. The processes described in these sections interact with each other. The clinical evaluation process receives information form the risk management process but also gives input into the risk management process. When the product is launched, the PMS activities start in parallel and collects reactively and proactively clinical data. This output affects the clinical evaluation and therefore the risk management processes as well.

This is also a circle with different interactions: the clinical evaluation provides input into the PMS plan. It is obvious to conclude that the clinical evaluation interactions with the PMS as well as the risk management processes.

These 3 processes form the base for the assurance of the wellbeing of the user/patient. It also is the base for several documents related to the device such as the IFU and the summary of safety and performance which are shared with the public.

Panel Discussion

More details and speakers involved soon

22 September 2021
Morning CEST
SESSION 3: In-Vitro Diagnostics
New Classification System and Rules for IVDR
Sascha Wettmarshausen - Head of Regulatory Affairs at VDGH e.V. (German IVD-Association)

Under the IVDR, the system of how products are placed on the market has been completely revolutionized. Under the old regime of the IVD directive, there was no direct division of products by class. Besides the products that required a Notified Body (Annex II A/B + self-tests) to CE mark products, all other tests were previously grouped under ” diverse”.

This has changed completely: Under the IVDR, there are 4 risk classes (A-D) grouped according to the risk of the disease/condition and consequent misdiagnosis to the patient. 7 rules and 10 implementing regulations specify how the respective products are classified.

In addition, the relevant body for the implementation of the IVDR (MDCG) has issued a living guidance document on classification.

Technical Documentation for IVDs according IVDR: a Case-Study
Stefanie Giesener - Head of Quality Management & Regulatory Affairs at DiaSys Diagnostic Systems GmbH, Germany

How have manufacturers implemented the IVDR requirements into their Quality Management System?

This presentation will give an overview of the regulatory requirements followed by examples to demonstrate how a manufacturer has implemented the requirements in its QMS:

  • The individual elements of the technical documentation, where they come from, what they must contain will be explained and demonstrated with examples.
  • A deep dive into the challenges for a manufacturer to fulfil those requirements and adjust existing processes and structures. Differences based on risk classification and the resulting consequences.

The lecture concludes with a question and answer session.

IVDR Implementation & Audits in the time of Corona Pandemic
Krutarth Patel - Vice President QM / RA at R-Biopharm AG

IVDR implementation during the uncertain time of Corona Pandemic remains challenging. Almost all organizations were forced to adjust/delay the IVDR program implementation. The whole process of Implementation became challenging due to compulsory home office rules, focus shift to Corona Tests, lack of notified bodies, Reference labs, and Audits (Internal and external).

During this session, we will present a case study on the IVDR implementation during COVID-19 pandemic.

Post-Market Surveillance for In-Vitro Diagnostic Medical Devices
Marta Carnielli - Technical Officer IVD at TÜV SÜD

The presentation will focus on:

  • An overview of the PMS requirements under the IVDR and their impact on Technical Documentation
  • Current status of guidance on PMS for IVDs: what guidance documents are already available and which are still expected after the IVDR Date of Application
  • Notified Body perspective
23 September 2021
Morning CEST
SESSION 4: Regulatory Management
Potential of Digital Documentation: Advantages, Disadvantages, and Future Trends
Sarah Panten - Strategic Business Development at avasis solutions GmbH

Most medical device companies still work with Word, Excel and PDF files which leads to inefficiency when it comes to creation and maintenance of the technical documentation. This presentation summarizes current challenges with the MDR and in particular for clinical evaluation, PMCF and PMS processes.

Key problem is the reuse of single information across different documents, which results in copy and paste of text elements or references between different documents. Since documents are changed quite often, inconsistencies are inevitable. On the other hand, Notified Bodies often ask for “stand alone” documents including the complete relevant content. In summary: Manufacturers and Notified Bodies have different perspectives on the technical documentation, often resulting in unnecessary discussions and findings that extend the regulatory approval procedure.

Software tools provide a solution for that dilemma, but the implementation is often associated with lots of time, money, and the need for extensive internal resources. Advantages but also disadvantages of software tool implementations are explained and the potential of a unified data model for medical devices highlighted. At the end, an outlook is given on current trends and how creation, maintenance and review of the technical documentation will change in the next 5 years – for medical device manufacturers but also for Notified Bodies.

Medtech Regulatory Overview and Tips to Get Registration Approval Quicker in Asia
Jack Wong - Founder at Asia Regulatory Professionals Association (ARPA)

Overseeing the implementation of standards and regulations for medical devices, while allowing a business unit to remain in compliance with those regulations is one of the biggest challenges of the MedTech industry under the MDR.

The process requires regulatory managers to be knowledgeable in the nature and application of regulations. Still when facing far away geographical areas, such as China, they may find it difficult to avoid any type of censure from government agencies or even from colleagues working abroad.

Through this interactive talk, we will address, among others:

  • What are the importance of Regulatory Management.
  • What are the key terms and regulatory systems for the Medtech industry.
  • Tips to get product registration approval quicker in Asia.
  • Cultural communication barriers in international business.
24 September 2021
Morning CEST
SESSION 5: Software Medical Devices
Cybersecurity Requirements for Software as Medical Device (SaMD)
Leon Doorn - Head of Regulatory Compliance [PRRC, DPO] at Aidence

During this session we will take a deep-dive into the requirements around Cybersecurity for medical devices and touch on the definition of requirements, testing and risk management.
Among others, we will address:

  • What are the sources for cybersecurity requirements for SaMD (MDR 2017/745, FDA, other)
  • Which are the requirements coming forth from Medical Device Standards (e.g. ISO 27001, IEC 82304, other)
  • What do you need to consider with regards to Security Risk Management for SaMD?
  • Are there specific risks for AI SaMD?
  • How do you validate Cybersecurity for medical devices?
  • How does your cybersecurity approach link to the Clinical Evaluation Report (CER)?
How to make Market Access Pathways Work for Digital Health Solutions
Danny Van Roijen - Digital Health Director at COCIR

In a society that is becoming increasingly digital, the use of digital health solutions in healthcare is often less common or available than we might expect. As national authorities search for new and better ways to assess innovative technologies, overall coordination is often lacking and can lead to a heavily fragmented European market. Inconsistencies in market access requirements are increasing the time and costs of bringing digital health solutions to market.

Based upon several national case studies we will discuss opportunites and challenges, and present recommendations to make digital health solutions more accessible to European citizens and patients.

Additional Considerations for the Clinical Evaluation of Artificial Intelligence Driven Devices
Encey Yao - Regulatory Manager at Qritive Pte. Ltd

Artificial intelligence (AI)-driven devices are constantly developed, yet are forced through conventional clinical evaluation criteria globally. The AI technology in question demands AI-centred validation. Key ideas such as

  • interpretability and explainability of outcome,
  • device accuracy performance studies vs agreement studies,
  • arriving at a suitable sample size to prove the clinical validity,
  • developing ground truth or gold standard methods as the reference points, and
  • validating devices at their intended application

are some of the existing questions clinical evaluators must reconsider when validating an AI-driven device.

Unfortunately, as there is a general lack of industry-wide guidance for clinical evaluation of AI-driven devices, how can stakeholders diligently work to ensure a high-quality AI application is administered in clinical settings? Until a recognised industry standard is established for AI medical / IVD devices, a large portion of clinical evaluation studies ought to be highly customised to the AI technology in question.

Speakers
Francesco Dell'Antonio
Info Scientific Board

Francesco Dell'Antonio

Vice President, Regulatory Affairs and Quality Assurance at Quanta System
Francesco Dell’Antonio, VP regulatory & quality of Quanta System Spa (El.En Group), biomedical engineer with 15 years experience in the medical device industry in either notified body and manufacturing companies. Strong expertise in complex active medical devices with software (in particular medical laser devices), with a high focus on the access to key regulated markets (EU, US, Korea, Japan, Canada, Brazil etc), with impressive success track in international approvals.
Laura Michellini
Info Scientific Board

Laura Michellini

Scientific Director at Contract Research Organizations Latis Srl and Elle Research Srl
Graduated in Chemistry and Pharmaceutical Technologies at the University of Genoa, she has more than twenty years of experience in the field of CROs. She has worked as Project Manager for numerous clinical projects for the most important pharmaceutical companies and for Health Institutions. After having held the role of Clinical Operation Manager at a CRO for some years, Laura is now the Scientific Director of Latis Srl and of Elle Research Srl, two CROs that deal with the design and conduct of pre and post-market clinical studies with medical devices, supporting manufacturer in the acquisition of clinical data on their products.
Sascha Wettmarshausen
Info Scientific Board

Sascha Wettmarshausen

Head of Regulatory Affairs at VDGH e.V. (German IVD-Association)
Sascha Wettmarshausen was involved in the entire legislative process of the IVDR and in constant contact with the EU Parliament, the Council and the Commission. At the VDGH, Mr. Wettmarshausen is responsible for the entire area of regulatory affairs (7 committees and working groups) and is heavily involved with the European association Medtech Europe (MTE). At MTE he holds the position of the Vice-Chair of the Regulatory Affairs Committee and is involved in 5 further working groups. Furthermore, he was involved in various guidance documents and is in close contact with the German Notified Bodies and other stakeholders.
Arkan Zwick
Info Scientific Board

Arkan Zwick

Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharmaceutical, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than eleven years of regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device, combi products and cosmetic compliance projects as well as in house legal advice for contract management, merger and acquisition, and intellectual property projects. He is responsible for the company’s regulatory compliance in the EU working with several notified bodies and for global market authorizations in the Americas and Asia-Pacific. Arkan has a master’s degree in Law from the University of Vienna and a PhD in European Law. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. He is fluent in English, German and French.
Bassil Akra
Info Speaker

Bassil Akra

CEO at QUNIQUE Group
Dr. Bassil Akra is the CEO and co-owner of QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and Switzerland. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and the globally the notified body association in the various European discussion. Dr. Akra was the Vice President for strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH in Germany. He has long experience in leadership, business management, research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system.
Marta Carnielli
Info Speaker

Marta Carnielli

Technical Officer IVD at TÜV SÜD
Marta Carnielli works for TUV SUD as IVD Technical Officer; in this role, she is responsible to gather and distribute regulatory information in the IVD field, represent TÜV SÜD in relevant regulatory committees and conferences and support management and technical experts with the interpretation of regulatory requirements. She is the Co-Chair of the IVD Notified Bodies Working Group. Prior to joining TÜV SÜD, Marta worked for Ortho Clinical Diagnostics where she held various roles of increasing responsibility within Customer Technical Support and the Quality, Regulatory and Compliance department. In her most recent role she was Senior Manager, QRC EMEA; in this role she was responsible for quality, regulatory and compliance activities related to the commercial business in Europe, Russia, CIS, Africa and Middle East.
Silvia Casagrande
Info Speaker

Silvia Casagrande

Clinical Evidence Manager at Orthofix SRL
Dr. Silvia Casagrande works as Clinical Evidence Manager in the Clinical Affairs department in Orthofix SRL. In her role Silvia defines and execute the clinical strategy for CE marking & FDA clearance/approval products in development, manages the preparation and update of CERs, PMCF plans and reports, and SSCPs. She is also involved in the preparation of operative techniques and Instructions For Use leaflets. Before she worked as Clinical Regulatory Lead in the Global Regulatory Compliance team in BSI where she was involved in the development of the processes for clinical evaluation and post-market requirements and in monitoring, maintaining and improving these processes. She also contributed to regulatory supervision of clinical oversight process and delivered internal training in these areas. Silvia holds a MSc in Pharmaceutical Biotechnology from University of Padua, Italy and a PhD in Cancer Biology from ETH Zurich, Switzerland.
Maurizio Cuocolo
Info Speaker

Maurizio Cuocolo

Head of Quality Management Unit at OPIS Srl
He was graduated in October 2008 in Pharmaceutical and Technological Chemistry. After a brief working experience as Polyvalent Technical Operator in research and development at Enervit S.p.a, He undertook important working experiences in Clinical Research. In detail, He worked as Study Coordinator at Oncology Department of San Gerardo Hospital in Monza and later, as Quality Assurance and Auditor GxP since 2011, at CROss Research S.A in Mendrisio. Since December 2017 he covered the role of Lead Quality Assurance and GxP Auditor at 3B Biotech Research Sagl in Lugano. On August 2019 he joined to PSI, international CRO Company, acting as Global Quality Assurance Auditor. Since January 2020 he covers the role of Head of Quality Management UNIT for OPIS Srl. Over the years he have achieved skills in the Clinical Trial Management as well as in the check of compliance to GxP, Guidelines and Regulations, developing a global overview useful to understand the critical aspects related to a clinical trial and clinical investigations with medical devices. He is member of Medical Devices SIMeF Group, He is coordinator of SIMeF GIQAR GCP Group, coordinator of GDPR Privacy SIMeF Group, member of GDPR AICRO Group, member of Farmaceutica Younger Group.
Leon Doorn
Info Speaker

Leon Doorn

Head of Regulatory Compliance [PRRC, DPO] at Aidence
Leon is responsible for Regulatory Affairs within a scale up company, who are developing AI solutions to detect abnormalities in imaging. He is working for over 12 years in the medical industry, within the quality and regulatory field and has gained his specific knowledge on Artificial Intelligence while working at Aidence.
Stefanie Giesener
Info Speaker

Stefanie Giesener

Head of Quality Management & Regulatory Affairs at DiaSys Diagnostic Systems GmbH, Germany
Stefanie Giesener has continuously worked for various companies in the medical device industry in the field of quality management and regulatory affairs since 1995. Since 2009, she is Head of Quality Management & Regulatory Affairs at the German IVD manufacturer DiaSys Diagnostic Systems GmbH. Beside her responsibilities in these companies, she was already engaged since 1997 in various committees in the German association of IVD manufacturers (VDGH), and in the European association (MedTech Europe) as well. In 2017 she became Member of the board at VDGH. She has already accompanied IVD manufacturers in their migration from the German Arzneimittelgesetz (AMG) to the European In vitro Diagnostic Directive (98/79/EC) and now she is responsible for the implementation of the IVDR at DiaSys.
Kelly Goodwin Burri
Info Speaker

Kelly Goodwin Burri

Senior Clinical Evaluation Specialist at Stryker
Kelly Goodwin Burri is a Senior Medical Writer and Clinical Evaluation Specialist with more than 15 years of experience in medical writing, clinical research, and epidemiology. Her professional experience includes various medical writing roles in the pharmaceutical industry, operational management of multi-national clinical trials and cohort studies, as well as project leadership roles for international patient registries. She currently serves as the Chair of the Medical Device Special Interest Group for the European Medical Writers Association (EMWA).
Jan Bart Hak
Info Speaker

Jan Bart Hak

Head Medical Device Department at ProPharma Group
Jan-Bart Hak is heading the medical device department of ProPharma Group, in Leiden, the Netherlands. He and his team provide services, internationally, in various medical device related areas such as quality management systems, regulatory affairs, clinical strategy, vigilance and product development. Prior to ProPharma Group, Jan Bart held different management positions in clinical and regulatory affairs at international oriented companies, such as Xendo, QPS and Cordis (Johnson & Johnson). He also worked at a start-up company in biodegradable medical devices, which is currently a successful company. As a Medical Biologist, Jan Bart holds a Ph.D. degree in cardiac physiology.
Sarah Panten
Info Speaker

Sarah Panten

Strategic Business Development at avasis solutions GmbH
Sarah has a background in medical technology and worked in various positions since 2007. She first worked as international product manager for Olympus Surgical Technologies Europe, before she entered the QM and RA world as consultant for Prosystem AG (NSF) in 2010. With her gained knowledge and expertise, she joined the established startup iThera Medical where she was responsible for coordination of development and market access activities for the world’s first optoacoustic tomography CE marked medical device. In that position, she introduced digital processes and digital technical documentation from the very beginning and realized the huge potential for digital solutions in the medical device industry. Based on that experience, she joined avasis in 2019 and is now focusing on the development and implementation of medical device specific software solutions.
Krutarth Patel
Info Speaker

Krutarth Patel

Vice President QM / RA at R-Biopharm AG
Dr. Krutarth Patel works at R-Biopharm AG in Germany as a Vice President for QM / RA, he has more than 10 years of experience In Vitro Diagnostics with hands on experience with ISO 13485, ISO 9001 and MDSAP, Council Directives In Vitro Diagnostics IVDD 98/79/EC and IVDR. Dr. Patels had various positions during his professional career in IVD industries e.g. Marketing & Sales, Clinical Affairs, Product Management, R&D, Production and as an Auditor. Dr. Patel holds Bachelor in Pharmacy, Masters in Biotechnology and PhD in Tropical Medicine.
Wiebe Postma
Info Speaker

Wiebe Postma

Sr Consultant & CRO Lead at Qserve CRO
Wiebe Postma, PhD is a Sr Consultant and CRO Lead at Qserve group with close to a decade of experience in the medical device industry. A generalist with in-depth knowledge of the medical device regulations and clinical operations, his goal is to help manufacturers find practical solutions to clinical data collection and regulatory compliance. He has been involved in the setting up of pre- and post-market clinical investigations with medical devices in Europe, as well as clinical evaluation and post-market clinical follow-up planning for a broad range of devices and indications. In recent years, he had a leading role in the growth of Qserve’s CRO services.
Jasminka Roth
Info Speaker

Jasminka Roth

Founder and Director of The Tao of Excellence
Jasminka Roth is the founder and director of The Tao of Excellence. A company that provides services for strategic quality management and smart process design that is located in Switzerland - a global leader in medical technology and a hub for innovation in the industry. Jasminka is passionate about developing integrative and holistic approaches to business challenges in quality management and strategy and enabling sustainable solutions at every stage. Her leadership in quality management and business excellence for a number of high-profile companies, such as Johnson & Johnson, Novartis and a multitude of highly innovative small and midsized medical device companies has given her the specialist insight that enables her to implement creative, innovative and lasting solutions. Her long-standing experience and expertise spans healthcare, pharmaceuticals and the medical devices industry, and she is actively interested in affecting change and strengthening Switzerland’s industrial standpoint in these sectors. Jasminka holds a MSc and BSc in biochemistry and biotechnology from ETH Zürich and has carried out research at the Insel Spital in Bern and at the University of Sydney, Australia.
Itoro Udofia
Info Speaker

Itoro Udofia

MHS-UK Director at TÜV SÜD
Dr. Itoro Udofia is MHS-UK Director at TUV SUD (UK). Itoro was formerly the Head of Notified Body at UL, and spent over nine years at BSI where he held several positions (including, Product Specialist, Global Head of Orthopaedics and Dentals Devices, and Head of Operations and Training). Itoro has over eighteen years of experience working with orthopaedics devices. Itoro’s qualifications include: BEng (Hons.) Biomedical Engineering and PhD Biomedical Engineering and Computational Modelling. He is a past visiting Professor at Wuhan University of Science and Technology in China.
Danny Van Roijen
Info Speaker

Danny Van Roijen

Digital Health Director at COCIR
Danny Van Roijen is Digital Health Director at COCIR. Danny holds a Master in Business Engineering and has 15 years of experience as a public affairs professional. Coordinating the association’s digital health acitivities Danny focuses on European policy making, covering topics such as artificial intelligence, blockchain, cybersecurity, data protection, interoperability and mHealth. Danny represents COCIR in the AI4People initiative and several EU-funded projects. Danny is also a member of the Stakeholder Cybersecurity Certification Group, established by the European Commission under the EU’s Cybersecurity Act. On behalf of COCIR, Danny is chairing the Healthcare working group within the International Association for Trusted Blockchain Application (INATBA). COCIR is the leading European trade association representing the medical imaging, radiotherapy, electromedical and health IT industries.
Jack Wong
Info Speaker

Jack Wong

Founder at Asia Regulatory Professionals Association (ARPA)
Over 25 years of Regulatory, Quality, Clinical Trial and Pharmacovigilance experience in Asia with good knowledge in the field of Nutritional, Pharmaceuticals, Medical Devices, Consumer Healthcare and Biological products. Externally, playing a leading role among all the Regional Regulatory professionals in AHWP (Asian Harmonization Working Party). Developed the First Asia Regulatory Affairs Certificate course since 2007 with over 3800 students in industry, government and universities. Being the founder of ARPA (Asia Regulatory Professionals Associations) since 2010 with over 4800 members. Wrote the first Asia Regulatory Book, Handbook of Medical Device Regulatory Affairs in Asia, 2nd edition now. Adjunct Lectureship & Visiting Professorship with Nanyang Technological University (Singapore), Tohoku University (Japan), Beijing University (China), Chinese University of Hong Kong (Hong Kong), University of Hong Kong (Hong Kong), Taipei Technical University (Taiwan), University of Sydney (Australia), Dongguk University (Korea).
Encey Yao
Info Speaker

Encey Yao

Regulatory Manager at Qritive Pte. Ltd
Encey has been familiarising himself with medical device regulations since 2018 and actively following the specific regulations regarding standalone medical device software and digital health solutions. While developing a robust regulatory framework for a new Singapore-based AI developer that complies with international standards and is ready to adapt to upcoming regulatory requirements such as the MDR and IVDR, he also participated in discussions that went into the industry position paper – Digital Health Regulation in Asia-Pacific: Overview and Best Practices. Inspired by the criticality of the medical device industry, Encey is passionate in medical research and improvement in healthcare systems. He is currently building a community of AI Medtech experts to further galvanise the adoption of AI technology into clinical practice.
Contacts

Laura C Collada Ali
MedDev Day Scientific Coordinator
medicalwriting@lsacademy.com
+39.320.3671224

Ilaria Butta
Events & Training Executive
ilaria.butta@lsacademy.com
+39.379.1492960


Registration Fee

Full attendance | 5 sessions
€ 640,00* Early Bird fee until July 21st, 2021
€ 720,00* Ordinary fee
€ 370,00* Freelance, Academy, Public Administration

General sessions 1 and 2 + 2 sessions based from your interest
€ 580,00* Early Bird fee until July 21st, 2021
€ 650,00* Ordinary fee
€ 330,00* Freelance, Academy, Public Administration

General sessions 1 and 2 + 1 session based from your interest
€ 420,00* Early Bird fee until July 21st, 2021
€ 470,00* Ordinary fee
€ 240,00* Freelance, Academy, Public Administration

* for Italian companies: +22% VAT

Fee includes: access to the virtual conference, organizational support, certificate of attendance, slide presentations in pdf format provided post-event.
Please remind to indicate in the box “note” the session/s you would like to attend while registering.

Past Conferences
2020
MedDev Day 2020
2019
MedDev Day 2019
Book Now
FULL ATTENDANCE - Early Bird
Available until 21/07/2021
640,00
FULL ATTENDANCE - Freelance - Academy - Public Administration
Available until 20/09/2021
370,00
GENERAL SESSIONS + 2 SESSIONS BASED FROM YOUR INTEREST - Early Bird
Available until 21/07/2021
580,00
GENERAL SESSIONS + 2 SESSIONS BASED FROM YOUR INTEREST - Freelance - Academy - Public Administration
Available until 20/09/2021
330,00
GENERAL SESSIONS + 1 SESSION BASED FROM YOUR INTEREST - Early Bird
Available until 21/07/2021
420,00
GENERAL SESSIONS + 1 SESSION BASED FROM YOUR INTEREST - Freelance - Academy - Public Administration
Available until 20/09/2021
240,00
Clear

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<p>Virtual conference with presentations, slots for Q&amp;A and discussion among delegates.<br />
<em>LS Academy will provide the link to join the conference some days before.</em></p>

Virtual conference with presentations, slots for Q&A and discussion among delegates.
LS Academy will provide the link to join the conference some days before.

<p>Virtual conference with presentations, slots for Q&amp;A and discussion among delegates.<br />
<em>LS Academy will provide the link to join the conference some days before.</em></p>