Dear Forum users
This is regarding getting biocompatibility testing of devices done from an external laboratory as per ISO 10993. What all the pre-requisites of choosing/ selecting/ qualifying an external laboratory for getting biocompatibility test done, including accreditation to ISO/IEC 17025 or equivalent but not just limited to. Is that a requirement mandatory by regulation (if I would market them to such specific countries, and if so, grateful if you explain such country specific regulation) or it is an added value to our product testing by such reputation?
Thanks and Regards
S. Subramaniam, INDIA
This is regarding getting biocompatibility testing of devices done from an external laboratory as per ISO 10993. What all the pre-requisites of choosing/ selecting/ qualifying an external laboratory for getting biocompatibility test done, including accreditation to ISO/IEC 17025 or equivalent but not just limited to. Is that a requirement mandatory by regulation (if I would market them to such specific countries, and if so, grateful if you explain such country specific regulation) or it is an added value to our product testing by such reputation?
Thanks and Regards
S. Subramaniam, INDIA
