Hi
sorry if this has question has already been asked, but I can't seem to find an answer.
Is it necessary to be certified to 13485 before ensuring conformity to 21 CFR Part 820, for sale of medical software in the USA.
We are a small biotech spinout, and the plan is to obtain FDA clearance first before launching in other countries.
We are not ISO 13485 yet.
Any advice or tips really appreciated!
Thanks very much!
sorry if this has question has already been asked, but I can't seem to find an answer.
Is it necessary to be certified to 13485 before ensuring conformity to 21 CFR Part 820, for sale of medical software in the USA.
We are a small biotech spinout, and the plan is to obtain FDA clearance first before launching in other countries.
We are not ISO 13485 yet.
Any advice or tips really appreciated!
Thanks very much!