Introduzione

The State of the Art section is not a new requirement under the EU MDR 2017/745. However, the requirements for this section have been enforced, and it became the fundament of the Clinical Evaluation Report.

The State of the Art section needs to identify benchmark devices besides information about the medical background, clinical conditions, and alternative therapies related to a medical device. Data about these benchmark devices are relevant to define safety and performance parameters and acceptance criteria. These criteria are used to compare the subject medical device to the current State of the Art. This requires a thoroughly structured systematic literature search and a deep understanding of the medical conditions related to the subject device.
Understanding the relevant parts of a State of the Art section and knowing where to start can be challenging, especially when writing your first Clinical Evaluation Reports.

Also, as a medical device professional, you may face devices with little background information for which the literature search can become a challenge.
Finally, the State of the Art section is subject to predefined review cycles and will also be included in other documents, such as the Summary of Safety and Clinical Performance (SSCP).

This workshop will give you profound insights into the regulatory requirements for the State of the Art, best practice recommendations on how to structure your search, and how to identify your benchmark devices and parameters.

  • Regulatory framework: EU MDR 2017/745 requirements and definitions
  • Content and structure of the State of the Art
  • Systematic literature searches for the State of the Art
  • Benchmark devices and benchmark parameters for safety and performance
  • How to compare the State of the Art information to the subject device
  • Review cycles and updates

This course is intended for medical device professionals with little or no experience in writing Clinical Evaluation Reports, including State of the Art Sections, under the Medical Devices Regulation 2017/745 (MDR).

Participant experience
We will assume that participants have basic knowledge of the directives and regulations governing medical devices, such as the MDR.

Lecturers will deliver short presentations on the program topics. Questions and subsequent discussions are welcome at any time during the workshop.

A series of polling questions will be used to illustrate participants’ ideas and perceptions on the topics presented. In breakout rooms, small groups of participants will have the chance to work on exercises related to the State of the Art section.

Docente/i
Katharina Friedrich
Info

Katharina Friedrich

MD – Freelance Medical Writing Consultant
Katharina Friedrich is a medical writer with experience in MDR regulatory writing. She is based in Heidelberg, Germany and works as a Freelance Medical Writing Consultant with focus on orthopedic and cardiovascular devices. She prepares Clinical Evaluation Plans and Reports, PMCF Plans and Reports and SSCPs in compliance with MDR 2017/745 for class I to class III devices. She also supports development projects and the conduction of PMCF activities. As medical doctor she has experience in the field of orthopedic and trauma surgery.

Laura C Collada Ali
Info

Laura C Collada Ali

Freelance Medical Writing Consultant, LS Academy Scientific and Medical Writing Coordinator
Laura is a medical writing consultant with more than 20 years of experience in delivering multilingual authoring services for leading pharmaceutical and medical device companies. She regularly prepares CEP, SSCPs, and PMCF related documents for medical devices in the fields of orthopaedics, cardiology, dermatology, and infectious diseases among others.

This online training consists of 1 module:

15 September 2022 – from 9:00 am to 1:00 pm CEST

Some days before the online training 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.

Early Bird: € 495,00* (until 18 August 2022)

Ordinary: € 625,00*

Freelance – Academy – Public Administration**: € 370,00*

* for Italian companies: +22% VAT

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

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

Acquista
Early bird
Acquistabile fino al 18/08/2022
495,00
Ordinaria
Acquistabile fino al 14/09/2022
625,00
Freelance - Accademia - Pubblica Amministrazione
Acquistabile fino al 14/09/2022
370,00
Svuota

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Know the requirements for the State of the Art section under EU MDR 2017/745
Risultato atteso
Structure a systematic literature search for relevant background information
Risultato atteso
Identify benchmark devices and safety and performance parameters
Risultato atteso
Know how to structure the information for your State of the Art section

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>