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Hello all,
I'm working at a company which provides regulatory consulting services for companies developing medical devices.
One of our costumer is a company which its product is a surgical scalpel with a special agronomic handle (the scalpels are for single use and will be supplied sterile).
My question is regarding the packaging. Do surgical instruments, such as these scalpels have to be double packed (e.g. double pouch) or is a single package (a blister) good enough?
I could not find a specific requirement on the standards and guidelines.
Thanks.
I'm working at a company which provides regulatory consulting services for companies developing medical devices.
One of our costumer is a company which its product is a surgical scalpel with a special agronomic handle (the scalpels are for single use and will be supplied sterile).
My question is regarding the packaging. Do surgical instruments, such as these scalpels have to be double packed (e.g. double pouch) or is a single package (a blister) good enough?
I could not find a specific requirement on the standards and guidelines.
Thanks.