4611063-EN
Training Design Control in the field of medical devices
Instructor-led Training2 Days
ENBeginnerPräsenztraining
The success or failure of new medical devices is already fundamentally determined at the product development stage. The focus is not only on safety, but also on usability and efficiency. This seminar clarifies the essential elements of instrument design control following 21 CFR 820 (FDA), ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP). You will learn the basic terminology and practical methods and examples of its use will be provided. You will always keep an eye on the entire product life cycle, from the product idea to the end of product marketing.
Day 1:
- Fundamentals of Design Control
- Overview of the current state of legislation (21 CFR 820) and standards (ISO 13485:2016)
- Design and Development Planning
- From User Needs to Design Input
- Design Verification, Results, and Validation
- Design Transfer
- Design Reviews
Day 2:
- Implementation-focused workshop to create the essential elements of a DHF (Design History File) using a real-world example from the field of non-active medical devices
- User Needs and their translation into Design Input
- Design and Development Plan
- Design Verification and Validation
- Statistical Sampling Plans
- Design Change Management
- DHF (Design History File) and Design Development File
- Managing external and older documentation
- You know how to develop medical devices in compliance with ISO 13485:2016.
- You will gain expertise in creating development documentation according to 21 CFR 820.
- You will learn the essential elements of the Design Control tool
Individuals involved in the development of medical devices such as:
- QM specialists
- Developers
- Project managers
- Regulatory affairs
- Managers with development responsibility
- Consultants
- Service providers
- This seminar covers internationally applicable standards and is also suitable for conducting abroad.
- The content of the seminar is in line with the current state of standardization.
- This seminar is part of a modular training program. Upon successful completion of the advanced modules, you can earn the following recognized certification: Safety Expert (Non-)Active Medical Devices – TÜV.
English
Certificate of attendance from TÜV SÜD