B
bennylee
Dear All,
Our company would like to send part of design to outsourcing company, may I know if such company must have ISO13485? or "approved by our company" is enough ?
"What we planed to do" is
For other part of technical file (FMEA, usability, clinical evaluation & 60601-1 certification application), surely, it will be done by our company.
Our company would like to send part of design to outsourcing company, may I know if such company must have ISO13485? or "approved by our company" is enough ?
"What we planed to do" is
- We provided our requirement in details (for hardware, software, mechanical only)
- such outsourcing company designed based on our requirement
- such outsourcing company provided samples & test report (using qualified equipment)
- We checked & approved & signed their document by our company
For other part of technical file (FMEA, usability, clinical evaluation & 60601-1 certification application), surely, it will be done by our company.