Module15 April 20263 min read
Module spotlight: Product Release
Nothing ships until the evidence says it can. Product release is the controlled final gate that confirms a product meets every requirement before it leaves your hands.
By MoniDoseQMS Team
Product release is the last line of defence before a device reaches a patient. It is the controlled decision — backed by evidence — that a product has met every requirement and is cleared to ship.
What you can do
- Gate product release behind the required approvals
- Confirm manufacturing records and checks are complete
- Apply electronic signatures to the release decision
- Keep a traceable record of who released what, and when
Why it matters
ISO 13485 §8.2.6 requires that product is not released until planned arrangements are complete. A controlled release gate, with the evidence already assembled, makes that decision both rigorous and quick.