Technical Documentation for Medical Devices according to MDR
Ensure your medical device documentation meets the latest EU regulatory standards with our focused 1-day training course on Technical Documentation for Medical Devices according to MDR (EU Regulation 2017/745). Designed for professionals involved in regulatory compliance, this course provides practical guidance on structuring, managing, and maintaining technical documentation that aligns with MDR requirements and supports smooth cooperation with notified bodies and competent authorities.
By the end of this course, you will:
- Understand the legal and regulatory framework for medical devices in Europe.
- Be familiar with the structure and content of technical documentation under MDR.
- Learn how to implement and manage compliant technical documentation in your organization.
- Gain insights into risk analysis, clinical evaluation, and documentation control.
- Be prepared to support conformity assessment procedures and interactions with notified bodies.
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
Who Should Attend?
This course is ideal for professionals involved in the preparation and management of technical documentation, including:
- Regulatory Affairs Specialists
- Quality Management Personnel
- Product Managers
- Compliance Officers
- Authorized Representatives
- Medical Device Manufacturers
Course Agenda
- Overview of the requirements for the content and structure of technical documentation for medical devices
- Legal framework for medical devices in Europe
- Requirements of the MDR (Medical Device Regulation)
- Technical documentation and conformity assessment procedures
- Technical documentation and competent authorities
- Content and structure of technical documentation
- Control and availability of technical documentation
- Essential elements of technical documentation, including risk analysis, evidence of selected topics, clinical evaluation
- Documentation management, e.g. PSUR (Periodic Safety Update Reports)
Course Description
As a manufacturer or authorized representative of medical devices, this seminar will provide you with a brief introduction to the regulatory environment of technical documentation and guidance on the systematic structure and change management of technical documentation for medical devices. The technical documentation should not only meet the legal requirements, but also enable smooth cooperation with the notified body and the responsible authorities, e.g. when carrying out your conformity assessment procedure for CE marking. You will learn about the key elements of technical documentation and why, for example, risk analysis is an integral part of it. The content is illustrated using practical examples. After the training course, you will be able to correctly implement the requirements of the European Medical Device Regulation 2017/745 for technical documentation in your company.
Benefits
Gain the knowledge and confidence to ensure your technical documentation meets MDR requirements. Whether you're new to regulatory affairs or looking to refresh your knowledge, this course will equip you with the tools to succeed.
- You will be familiar with the requirements for compliance with EU Regulation2017/745 (MDR) for the technical documentation of your medical devices.
- You will acquire knowledge of the content and structure of technicaldocumentation for medical devices.
- You will be able to create your own legally compliant technical documentation.
Methodology
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.
Learning Assessments
Participants will receive a Certificate of Attendance from TÜV SÜD Academy upon completion.
Prerequisites
No prerequisites or prequalifications necessary.