Content
From the idea for developing a medical product to the production of the pilot series and handover to production, a large number of regulatory requirements must be adhered to. The EU MDR only reflects one part of the requirements, albeit the most important one for the European market, but in many cases it is supplemented by other directives, regulations and laws. Wherever approval is sought, it must be explicitly demonstrated how the medical device was developed and how it was ensured that it is safe and functional. Elementary components of this proof are the verification of the development results based on a specification (design verification) and the validation of the product against the requirements of the specifications and specifications (product validation). A regulatory requirement that is now found worldwide.
The seminar presents the steps for preparing and carrying out design verification and product validation. Using a practical example, a possible path from the idea to the “finished” product is shown, which provides sustainable evidence and avoids the typical pitfalls.
Topic overview
- Introduction, example
- Development processes (from the idea to the product)
- Specific requirements for the development of medical devices
- Special features of the requirements for Design Verification (DV) and Product Validation (PV) from the different approval regions
- Development of a DV and PV strategy for a product
- Documentation of DV and PV
- Differentiation from other validation tasks
target group
Employees from product development, production, quality assurance and regulatory affairs.
Prior knowledge
Basic knowledge of dealing with regulatory requirements and quality requirements is necessary.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
