Inspection and traceability of implantable devices

Answer:

I assume you are asking regarding ISO 13485 and not ISO 9001 since requirements for inspection and traceability only exist in ISO 13485.

ISO 13485 requires organization to document procedure for traceability defining extent of the traceability in accordance with applicable regulatory requirements and the records to be maintained. Specific traceability requirements for implantable devices include records of components, materials and, in some cases, conditions for the work environment used. All requirements regarding traceability of implementable devices can be found in clause 7.5.9.2 in ISO 13485:2016.

The only additional requirement for inspection regarding implementable medical devices includes recording the identity of personnel performing inspection or testing, the rest of requirements for inspection and testing are located in clause 8.2.6 of ISO 13485:2016.