How Manufacturers Can Create a Compliant Technical Documentation (TD)
Two-Day Applied Course
The preparation of Technical Documentation (TD) poses significant challenges for many manufacturers. Those who do not work carefully and fail to meet the regulatory requirements risk time-consuming and costly requests for clarification or corrective actions from Notified Bodies.
Manufacturers of medical devices must compile Technical Documentation for each individual product, as it is a prerequisite for CE marking and market access. Depending on the intended purpose and risk classification, specific requirements must be implemented in the TD. These derive from the General Safety and Performance Requirements (GSPRs) as outlined in Annex I of Regulation (EU) 2017/745 (MDR) and the related applicable harmonized standards, guidance documents, and common specifications.
In this seminar, you will learn not only about the many new and revised requirements but also how to prepare compliant Technical Documentation, avoid common pitfalls with practical advice, and successfully transition or update existing documentation.
- Content
- Introduction to Technical Documentation
- Regulatory requirements
- Relevant laws, directives, standards, and guidelines
- Fundamentals of EU medical device conformity assessment
- Requirements of the MDR according to Annexes II and III
- Developing documentation that is lean and pragmatic
- Structure, organization, and possible formats of Technical Documentation
- Consequences of non-compliant or deficient documentation
- Practical guidance for meeting the General Safety and Performance Requirements
- Your Benefits
- Gain a comprehensive understanding of the requirements for Technical Documentation under the MDR.
- Learn about different structure and formatting options for preparing TDs.
- Understand how to implement new and updated requirements efficiently and adapt existing documentation with minimal time and resource expenditure.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of medical devices and those planning to become one
- Regulatory Affairs professionals
- Quality Management personnel
- Individuals responsible for creating or maintaining Technical Documentation
