How Manufacturers create compliant Technical Documentation
Creating Technical Documentation (TD) poses challenges for many manufacturers. Those who do not work carefully during the creation process and fail to meet requirements risk not only time-consuming but also costly inquiries and additional requests from Notified Bodies.
Medical device manufacturers must provide technical documentation for every medical device, as it is a prerequisite for its approval. Depending on the intended use and risk classification, specific requirements for the TD must be implemented. These requirements stem from the applicable essential safety and performance requirements and the associated applicable standards, guidelines, and directives.
In this seminar, in addition to learning about the many new and revised requirements, you will discover how to create compliant technical documentation, which typical hurdles you can overcome with practical tips, and how to successfully update existing technical documentation.
- Content
- Introduction to Technical Documentation
- Legal Requirements
- Relevant laws, directives, standards, etc.
- Fundamentals of Product Authorization in the EU
- Requirements of the MDR according to Annexes II and III
- Designing Documentation to Be Concise and Pragmatic
- Structure, Possible Formats, and Format of Technical Documentation
- Consequences of Faulty Documentation Preparation
- Practical Tips for Meeting Basic Safety and Performance Requirements
- Your Benefits
- You will learn about the various requirements for technical documentation.
- You will learn about the possible structures, layout, and format of technical documentation.
- This practical course will show you how to implement the new and revised requirements and how to adapt existing documentation with minimal time and resources.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Manufacturers of medical devices and those who wish to become manufacturers
- Regulatory affairs staff
- Quality management staff
- Individuals who create technical documentation or are expected to do so in the future
