Discover the course

ONLINE TRAINING: The Medical Device Clinical Evaluation

Understanding the clinical evaluation requirements for the MedTech industry in the context of MDR 2017/745

Date

30 September and 1 October 2020

Location

Online

Language

English

ONLINE TRAINING: The Medical Device Clinical Evaluation

Significant regulatory changes are coming along with the EU Medical Devices Regulation 2017/745 (MDR), MEDDEV and MDCG (Medical Device Coordination Group) guidance evolutions affect the clinical evaluation of medical devices.

This online course gives participants an overview on the requirements for the clinical evaluation of medical devices and the impact of the MDR and guideline documents on clinical evaluation of medical devices. The course further describes how to prepare the new requirements from a clinical perspective including the MEDDEV 2.7.4/1 on clinical evaluation and the MEDDEV 2.12/2 on post market clinic follow up and MDCG Guidance on clinical evaluation for legacy devices, equivalence, sufficient clinical data.

The training will allow participants to obtain a clear understanding of the regulatory requirements and will give hands-on insight on how to achieve compliance with respect to the changing environment and new documents to be created such as the summary of safety and clinical performance (SSCP) and periodic safety update reports (PSUR).

The entire program is distributed in 2 modules, 3 hours each 

Day 1 | 9:30 am to 12:30 pm CEST

Part 1: Overview on Medical Devices requirements 

  • MDD vs MDR, what is new?
  • Clinical MEDDEVs, Standards, MDCG guidance
  • The ISO 14155:2019 revision
  • NB Guidelines
  • Impact on product claims and marketing

Part 2: The MDR requirements

  • MDR in a nutshell
  • Clinical evaluation and investigation
  • Equivalence approach

Part 3: Get ready to MDR from a clinical perspective

  • Gap analysis 
  • Clinical strategy
  • Processes and strategy with NBs


Day 2 | 2:00 pm to 5:00 pm CEST

Part 4: MEDDEV 2.7/1 rev 4 and MDCG guidance on clinical evaluation

  • Overview and NB key points
  • Good practice for equivalence justification including MDCG 2020-5
  • Sufficient clinical evidence for legacy devices MDCG 2020-6
  • Risk assessment and clinical

Part 5: MEDDEV 2.12/2 rev 2 on post market clinical follow up studies (PMCF)

  • Overview on PMSP, PMSR, PSUR, CER, PMCF
  • When to conduct PMCF
  • PMCF plan and evaluation report templates MDCG 2020-8 and 7
  • Role of the NB

Case studies / Q&A


Course Language

The online training will be in English

Arkan Zwick
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.

CEO/CTO´s, Regulatory Affairs . Quality Assurance . Clinical Department, Marketing or Business Development responsible working for medical device manufacturers, pharma and biotech companies, CROs, Research Centres and Universities applied sciences and biotechnology faculties.

Participant experience

Knowledge of the Medical Device Directive (MDD) 93/42 is an advantage. Newcomers are welcome.

Online training with case study discussion and Q&A sessions

Online Interactive Training

Online Training - 3 modules

September 30th, 2020             09:30 am – 12:30 pm CEST
October 1st, 2020                     02:00 pm – 05:00 pm CEST

After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Certificate of attendance

Early Bird: € 720,00* (until 9 September 2020)

Ordinary: € 830,00*

Freelance - Academy - Public Administration**: € 430,00*


*
for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Register now

Course Price

830.00 €

Early Bird

Wednesday, September 9, 2020

720.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

2 modules, 3 hours each

Course Type

Limited number of participants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Understand content of the new Medical Devices Regulation and its impact on the clinical evaluation of medical devices

  • Understand new elements in ISO 14155

  • Understand how to achieve compliance during the transition period

  • Use practical experience from industry perspective

Participants' Feedbacks

Lecturers know what they are talking about and are able to answer the questions. It's clear that they work and have experience in the field

The limited number of participants allows a better interaction with the teachers, who can answer all the questions

International and multidisciplinary profile of participants, which enriches the training

Variety of topics covered, which have been adapted to the different needs of the participants

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ONLINE TRAINING: The Medical Device Clinical Evaluation

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161), as the data controller, will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for, for the management of participation in the course, for sending the newsletter, and for dissemination purposes. You can read the complete information, including your rights and how to exercise them, following this link.