Design Control in the field of Medical Devices
- You will know how to develop medical devices in accordance with ISO 13485:2016.
- You will receive the know-how on how to create development documentation in accordance to 21 CFR 820.
- This seminar clarifies the essential elements of the Design Control instrument.
Individual involved in the development of medical devices, such as:
- QM specialists
- Project managers
- Regulatory affairs
- Managers with development responsibility
- Service providers
Day 1: Basics of design control
- Overview of the current state of legislation (21 CFR 820) and standardization (ISO 13485)
- Design and development planning
- From user needs to design input
- Design verification, output, and validation
- Design transfer
- Design reviews
- Risk based sampling plans
- Design change management
- Design history file (DHF) and technical documentation
Day 2: Workshop
- Creation of the essential elements of a DHF
- Derive a risk analysis at product level
- Dealing with external and older documentation
Developing medical devices safely.
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.
- This seminar deals with internationally valid standards and is also suitable for implementation abroad.
- The contents of the seminar correspond to the current state of standardization.
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.
Certificate of participation from the TÜV SÜD Academy.