Content
In addition to processes and software, manufacturers of medical devices must also validate test methods in order to demonstrate that test decisions can also demonstrate the conformity of products. The specifications in DIN EN ISO 13485 are unspecific, so many questions remain unanswered regarding the validation of methods.
Which test methods need to be validated? How do you proceed methodically? What are specific requirements? How do you implement a risk-based approach?
The aim of this seminar is to answer the questions and show ways in which test methods can be validated, tailored to a testing system and the associated testing task.
Topic overview
- Normative requirements and basic concepts of method validation
- Risk-based approach and analysis of methods in relation to validation scopes
- Overview of the most important tools and their application for determining correctness and accuracy
- Comparison of test methods
- Practical transfer based on examples from the participants
target group
Those responsible for validation, development engineers, validation engineers.
Prior knowledge
Not required.
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
