C
ckrasner
I am filling in gaps in our ISO 13485 for the purposes of CE marking and I am having trouble writing a Sterilization procedure (our product is gamma radiated at a subcontracted facility and then tested for sterility at a subcontracted lab) to fulfill 7.5.1.3 and 7.5.2.2.
I am having trouble because I am not expert in the particular procedures the companies use, but I do have a basic SOP and laboratory analysis reports.
Help! Any examples/templates would be marvelous too. Thanks!
I am having trouble because I am not expert in the particular procedures the companies use, but I do have a basic SOP and laboratory analysis reports.
Help! Any examples/templates would be marvelous too. Thanks!