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 prove the conformity of products. The specifications in ISO 13485 are unspecific, so many questions remain unanswered with regard to the validation of methods. Which test methods need to be validated? How do you go about doing this methodically? What are specific requirements? How to implement a risk-based approach? The aim of this seminar is to answer the questions and show ways in which test methods can be tailored to a test system and associated test tasks and validated.
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 group of participants
target group
Validation Managers, Development Engineers, Validation Engineers.
previous knowledge
Not mandatory.
KONTAKT:
Online
