Technical Documentation for Medical Devices

Learn how to ensure correct technical documentation for medical devices

Learn how to ensure correct technical documentation for medical devices

Course Description

During the seminar, you will get a brief introduction to the regulatory environment as well as a guide for the systematic structure and maintenance of the technical documentation for medical devices referring to Annex II/III of MDR (Regulation (EU) 2017/745). Your technical documentation not only have to be in compliance with the legal requirements, but also should be designed to ensure smooth cooperation with the Notified Body and the responsible authorities - for example in the conformity assessment procedure for CE marking.

You will become familiar with the key elements of the technical documentation and learn e.g., why risk analysis is an integrated part thereof. The contents are explained using practical examples what makes it easier to transfer them to your own company.

Course Contents

  • Introduction and overview of technical documentation for medical devices
  • Legal framework for medical devices in the EU
  • Amendments by Medical Device Regulation (MDR)/(EU) 2017/745
  • Technical documentation and conformity assessment procedures
  • Technical documentation and competent authorities
  • Contents and structure of technical documentation
  • Control and availability of technical documentation
  • Key elements of technical documentation
  • Risk analysis
  • Proof of sterility assurance
  • Stability in storage and transport
  • Clinical evaluation
  • Documentation management

Who Should Attend

  • Employees of medical device manufacturers, who will be in charge of or involved in the creation of technical documentation for medical devices
  • Personnel in regulatory affairs and quality management
  • PRRC(s)

Course Objectives

  • You will obtain proof of compliance with the EC Directive for the technical documentation of your medical devices.
  • You will acquire knowledge of the content and structure of technical documentation for medical devices.
  • You will learn how to create your own legal compliant technical documentation.

Requirements

No requirements are necessary.

Methodology

This seminar is a single training and addresses internationally valid standards.

Certificate

TÜV SÜD Academy certificate of attendance

Next Steps

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