hello,
I would appreciate any help with the following topics:
1. if I want to change the expiration date for a medical device (for example from 1 year to 2 years) - what testing is required?
2. can anyone please help interpret this statement from ISO 11607:
6.4.7 When it is demonstrated that the product does not interact with the specified sterile barrier system over time, previously documented data for stability testing shall be sufficient to be in accordance with 6.4.1.
thank you!
I would appreciate any help with the following topics:
1. if I want to change the expiration date for a medical device (for example from 1 year to 2 years) - what testing is required?
2. can anyone please help interpret this statement from ISO 11607:
6.4.7 When it is demonstrated that the product does not interact with the specified sterile barrier system over time, previously documented data for stability testing shall be sufficient to be in accordance with 6.4.1.
thank you!