record retention
Here are the regulatory requirements:
MDD (Annex II # 6.1) - at least 5 years after last product has been manufactured
Canada (Canadian Medical Device Regulation) # 55 - distribution records shall be maintained for the longer of (a) projected useful life of device and (b) 2 years after the date the device is shipped
US (QSR 820.180(b)) - records required shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution
Here are the questions you need to answer:
(1) what is the the life of the device? you need to define it, document it, and provide justification/rationale on how you come to this "magic number"
(2) from the life of device you have defined, what is the record retention period for quality records (e.g. SOPs, DHR, DHF, DMR, technical file/essential requirements, records, management reviews, internal audits, supplier files, audit reports and other communications from/to ISO registrars, complaints, C&R, MDRs, vigilance reports, etc)?
Some registrars recommended device life + 5 years. However, you need to define it to your devices besides meeting regulatory requirements.