The OEM will obtain them from either the manufacturer or their approved supplier, who will be ISO certified with full traceability. The OEM may also do their own quality control tests and checks before use. If there was a recal or other fault found the OEM would issue a field safety notice to be able to rectify the issue.

This is what is required by the medical device directive and is one of the reasons medical spare parts cost more than off the shelf parts. Most OEM follow ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes. How many of those repairing medical devices follow this?

Last edited by MikeX; 10/03/19 10:06 PM. Reason: Added ISO information