2023-09-26 2023-09-26 , online online, 1,190 € plus tax Prof. Dr. Stephen Gilbert https://www.forum-institut.com/seminar/23102506-crash-course-medical-device-regulation/referenten/23/23_10/23102506-crash-course-medical-device-regulation_gilbert-stephen.jpg Crash Course: Medical Device Regulation

Learn the essentials of the MDR and how to navigate around the legislation and to apply it.

Topics
  • Overview of the Medical Device Regulation
  • Responsibilities of the various parties
  • Quality management system requirements (ISO 13485)
  • General safety and performance requirements (GSPR)
  • Technical documentation and CE certification
  • Post-market surveillance: vigilance, PMCF and reporting


Who should attend
This online course addresses employees who have just started in the field of medical devices and need the essentials of the Medical Device Regulation.

This includes beginners as well as professionals switching area of expertise, e.g., from a pharmaceutical company to a medical device company. However, anyone needing an update on the MDR will also benefit from this crash course.
Aims and objectives
The MDR is a comprehensive set of rules that is a challenge at best, especially for people from outside the medical device industry. In this online crash course, you will learn how to apply the MDR, what it covers and where you can find specific references.

Among other things, you will learn what a medical device is, how it is classified, what the roles of manufacturers, authorised representatives, importers and distributors (MAID) are, and what requirements the MDR places on quality, safety and performance.

Eliminate any ambiguities and get an overview of the peculiarities of the MDR.
Your benefit

You will gain an understanding of the requirements for clinical evaluations, technical documentation, and post-marketing surveillance. By participating in the seminar, you will also be able to better navigate the regulatory landscape and ensure compliance with EU MDR regulations.

Crash Course Medical Device Regulation

Crash Course: Medical Device Regulation

Insights into the applicability and general structure of the MDR

Benefits
  • Get an overview about the European MDR
  • Bring your questions to the seminar and ask the experts
  • Perfect for entering the world of the regulation of medical devices in the EU

Webcode 23102506

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JETZT Buchen

Speakers


Everything at a glance

Appointment

19/10/2023

19/10/2023

Period

9:00 - 17:00You may dial in 30 min. ...

9:00 - 17:00
You may dial in 30 min. before the session
Venue

online

online

Fee
Your contact

Verena Planitz
Conference Manager

+49 6221 500-655
v.planitz@forum-institut.de

Details

Learn the essentials of the MDR and how to navigate around the legislation and to apply it.

Topics

  • Overview of the Medical Device Regulation
  • Responsibilities of the various parties
  • Quality management system requirements (ISO 13485)
  • General safety and performance requirements (GSPR)
  • Technical documentation and CE certification
  • Post-market surveillance: vigilance, PMCF and reporting


Who should attend
This online course addresses employees who have just started in the field of medical devices and need the essentials of the Medical Device Regulation.

This includes beginners as well as professionals switching area of expertise, e.g., from a pharmaceutical company to a medical device company. However, anyone needing an update on the MDR will also benefit from this crash course.

Aims and objectives

The MDR is a comprehensive set of rules that is a challenge at best, especially for people from outside the medical device industry. In this online crash course, you will learn how to apply the MDR, what it covers and where you can find specific references.

Among other things, you will learn what a medical device is, how it is classified, what the roles of manufacturers, authorised representatives, importers and distributors (MAID) are, and what requirements the MDR places on quality, safety and performance.

Eliminate any ambiguities and get an overview of the peculiarities of the MDR.

Your benefit

You will gain an understanding of the requirements for clinical evaluations, technical documentation, and post-marketing surveillance. By participating in the seminar, you will also be able to better navigate the regulatory landscape and ensure compliance with EU MDR regulations.

Detailed programme

9:00 - 17:00
You may dial in 30 min. before the session

Robert Lindner

The regulation and guidance documents
  • EU MDR and CE marking
  • Definition and classification
  • Combination products

Robert Lindner

Economic operators
  • Roles and responsibilities of the MAID
  • Competent authorities and Notified Bodies
  • Person responsible for regulatory compliance (PRRC)

Robert Lindner

Quality management system requirements
  • Article 10, 9
  • EN:ISO 13485:2016
  • Risk management

Dr. Stephen Gilbert

Annex I: General safety and performance requirements
  • Alignment with EN:ISO 13485:2016, clause 7.3
  • Clinical evaluation
  • Risk management
  • Summary of safety and clinical performance (SSCP)

Dr. Stephen Gilbert

Annex II: Technical documentation
  • Technical documentation (Annex II)
  • Notified body selection
  • Life cycle management

Dr. Stephen Gilbert

Clinical Evaluation
  • Purpose of Clinical Evaluation
  • Clinical Data
  • Clinical Evaluation Plan (Annex XIV) (CEP)
  • Clinical Development Plan
  • Clinical Evaluation Report (CER)

Dr. Stephen Gilbert

Post-Marketing Surveillance
  • PMS Plan
  • PMS Report
  • Setup and Implementation of PMS
  • PMCF
  • Vigilance

More information

PreMeeting & Technical Test

Get to know our Learning Space and gain confidence: You can attend one of our PreMeetings free of charge, registration is not required. You will find the dates and access data for our PreMeetings in your customer account. A PreMeeting offers you the opportunity to get to know our Learning Space better. It is a non-binding offer for all customers and not a prerequisite for your participation. If a PreMeeting date does not suit you, but you would like a technical check in advance, please contact us.

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