A medical device contract manufacturer has two audiences for every document: the device owner, who is legally responsible for the device, and the regulators and notified bodies who may inspect either of you. Work instructions, records and validations have to show that every unit was built the validated way, by trained people, and can be traced back to its materials.
ISO 13485:2016 is the quality management standard for medical devices. Compared with ISO 9001, it puts more weight on documented procedures, validation of production processes whose output cannot be fully verified, cleanliness and contamination control, identification and traceability, and keeping records for at least the life of the device. The ISO 9001 vs ISO 13485 comparison covers the differences.
In the United States, the FDA’s Quality Management System Regulation (QMSR) took effect on 2 February 2026. It amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference, kept a small number of FDA-specific requirements, and replaced the old Quality System Regulation. FDA inspections now follow an updated compliance program instead of the QSIT approach. See what changed from 21 CFR 820 to the QMSR and the QMSR readiness checklist.
The quality agreement decides who owns what. Typically the device owner holds the design history and the device master record content, and the contract manufacturer owns the production documents that carry it out: work instructions, inspection procedures, process validations, equipment and environment controls, and the device history record for each lot.
That split creates a specific risk: a design or labelling change approved by the owner has to reach your shop floor through your change process, on time, with the old revision withdrawn. Most contract-manufacturing findings sit somewhere in that hand-off.
| Page | Why it matters here |
|---|---|
| 21 CFR 820 SOP template | A procedure structure with purpose, scope, responsibilities and records for regulated work. |
| FDA QMSR transition guide | What the regulation now expects and how to plan the move. |
| Design history file guide | What the device owner keeps, and what they may ask you to supply. |
| Verification vs validation | When a process must be validated rather than inspected. |
| Cleanroom gowning work instruction example | A complete example for controlled-environment entry. |
| Engineering change notice template | Carries an owner-approved change into your documents with a clear effective point. |
| CAPA form | Investigation, correction and effectiveness check in one record. |
| Records retention schedule | Retention periods tied to device life and customer agreements. |
Example An excerpt from a work instruction at Brightline Medical Assembly, a fictional contract manufacturer. Parameters and limits are example values; use the values from your own process validation and the device owner’s specifications.
| Document | WI-PK-014, Example |
|---|---|
| Revision | E, implements owner specification PS-208 Rev C |
| Scope | Sealing pre-made pouches on sealer SL-02 in the controlled packaging area |
| Validated parameters | Temperature, dwell time and pressure per validation report PV-SL02-03 |
| Approved by | Quality engineer, production manager; owner approval on file |
These are the kinds of findings auditors and customers commonly write in this industry, with a way to prevent each one in the instruction itself.
Yes. The FDA’s Quality Management System Regulation took effect on 2 February 2026. It incorporates ISO 13485:2016 by reference into 21 CFR Part 820 and replaced the old Quality System Regulation.
No. Certification is useful evidence for customers, but the FDA does not accept it in place of its own inspections. Your system still has to meet the regulation as written.
Usually the device owner holds the design and specification content, and the contract manufacturer holds the production documents that implement it. The quality agreement should state this explicitly.
Processes whose result cannot be fully verified by later inspection or test, such as sealing, sterilisation, some bonding and some welding. The device owner and you should agree which ones apply.
COPLAIN JOB AID BUILDER
Upload an owner specification, validation report or existing SOP and Coplain’s Job Aid Builder drafts controlled work instructions with validated parameters, DHR entries and reject handling built into the steps.