Hello,
I have a big problem...
After an FDA inspection my company has to define a procedure for defining sample sizes regarding design verification.
My question is...how did you find a solution?
What are reasonable statictics standards i can use or refer to for defining sample sizes vor design verification tests? For example: electrical safety tests, software verification, mechanical durablility and loadability tests,...?
I am very thankful for every hint you can give me...
Best regards,
Aphel
I have a big problem...
After an FDA inspection my company has to define a procedure for defining sample sizes regarding design verification.
My question is...how did you find a solution?
What are reasonable statictics standards i can use or refer to for defining sample sizes vor design verification tests? For example: electrical safety tests, software verification, mechanical durablility and loadability tests,...?
I am very thankful for every hint you can give me...
Best regards,
Aphel