Test method validation
We have been certified recently. Nevertheless I still have some troubles with test method validation. It’s a very complex material.
Currently, I struggle to establish whether a validation has to be conducted on some benchmark or our product. The product of ours is being developed. Currently we found optimal conditions to conduct the trial of production process. Development of the product is promising so we’ve decided to validate a crucial process. Do you have any thoughts on that matter?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Validation must be performed in the cases when you are not able to verify the product by subsequent monitoring or measurements. Of course, validation of the product should be on the final product, not on the sample from the design. Therefore, as soon as you perform the transfer from the design to the real production, a process in which the final product will be produced must be validated. For more information on the validation, please provide a more specific question.
In the following link you can find some more details for the validation process:
- Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/
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May 26, 2021