Technical Documentation for Medical Devices

Instructor-led Training1 DayBeginnerVirtual Classroom
  • 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.
  • 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)
  • 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

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.

TÜV SÜD Academy certificate of attendance

Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.

The course content and structure are designed by the domain experts from TÜV SÜD.

With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.

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

No requirements are necessary.

Net Price (excl. TAX)
from$ 1,195.00

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From 19.Aug.2024
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Price (excl. TAX):
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