QMSR OUTSOURCED-MANUFACTURING DIAGNOSTIC
A fixed-scope engagement that tells you exactly where your evidence stands, what is genuinely missing, and who has to fix it, before you commit to a larger program.
THIS IS BUILT FOR YOU IF
- You are a U.S. specification developer or finished-device manufacturer
- You have one active Class II, or selected Class I, device family
- Manufacturing is substantially outsourced to China or Southeast Asia
- An audit, supplier transfer, design-file problem, or production milestone is approaching
- Your files are spread across folders, spreadsheets, email, and factory systems
We have run this work before
- Class II manufacturing transfer
- Flagship device moved from in-house production to contract manufacturing in China
- Class III supplier quality
- Multi-year China supplier-audit and quality program
- U.S. and China execution
- California program leadership with a Shenzhen quality and engineering team
- Engineering depth
- BOM Quote design, test, NPI and manufacturing when the fix is not a document
WHY THIS COMES FIRST
Most quality remediation projects are scoped before anyone knows what is actually missing. The result is a proposal built on assumptions, and a budget that moves once the real state of the evidence becomes visible.
This engagement exists to produce a defined answer instead. In under two weeks you get a map of what you have, a matrix of what is missing against the requirements that apply to your device, a written division of responsibility between your company and the factory, and a remediation plan ordered by risk and deadline. You can act on it with us, with another partner, or on your own.
WHAT YOU RECEIVE
Ten deliverables, every one of them a document you keep.
-
Device and regulatory-role map
Product classification, applicable requirements, and which regulated role each party actually occupies: specification developer, contract manufacturer, importer, labeler.
-
Audit and milestone scope confirmation
What the upcoming audit or milestone will actually cover, so remediation effort goes where it will be examined.
-
Existing-document and executed-record inventory
Everything that exists today, classified and, critically, separated into controlled procedures versus executed records.
-
Legacy Part 820 to current QMSR / ISO 13485 cross-reference
Your existing checklist mapped into the current framework, so work already completed is preserved rather than repeated.
-
Design file evidence map
Design and Development File (formerly the DHF) and Medical Device File (formerly the DMR) structure, plus production and batch records, showing which records fill which section and which are empty.
-
Requirement-to-document gap matrix
Each applicable requirement traced to the evidence that satisfies it, or flagged where nothing does.
-
Critical risk and V&V chain review
For your highest-severity hazards: does the chain from risk control to verification evidence to production test actually connect?
-
Specification-owner / factory responsibility matrix
A written allocation of who owns design, changes, validation, supplier approval, complaints, and records. This is the document most outsourced programs are missing.
-
Prioritized 30/60/90-day remediation plan
Ordered by regulatory exposure and deadline, with the work that requires factory presence identified separately.
-
Leadership readout
A briefing your executives and board can act on, in language that does not require a quality background.
WHAT THE GAP MATRIX LOOKS LIKE
Every applicable requirement traced to the evidence that satisfies it, the state of that evidence, and which company owns closing it.
| Requirement | Available evidence | Status | Owner |
|---|---|---|---|
| Design validation evidence | No executed report located | Blocker | Specification owner |
| Thermal cutoff production test | Procedure exists; recent executed records unavailable | Gap | Factory |
| Design transfer approval | Signed historical record located | Satisfied | Both |
| Critical component supplier approval | Certificate on file; no evaluation record | Gap | Specification owner |
Illustrative rows. The owner column is the one most programs have never written down, and it is usually where findings originate.
What we need from you to start
- The audit notice or milestone date, if one exists
- An index of your current documents and checklist
- ISO 13485 certificate, audit report, and any open findings or CAPA status
- Product, regulatory, risk, test, and safety-certification records you hold
- Design transfer and manufacturing records, or access to the factory's
- A named contact at your company and one at the factory
What the diagnostic does not include
This engagement finds and prioritizes gaps. Closing them is scoped separately, from the findings, so you are quoting real work rather than an estimate. Not included:
- Drafting every missing procedure
- Executing new verification or validation testing
- Completing process validation at the factory
- Translating an entire factory record estate
- Closing corrective actions
What happens next
- Most companies move directly into remediation, either at the factory or in their own design file
- Some take the plan and execute internally, which is a legitimate outcome the deliverables are written to support
- Where the work requires factory presence, our Shenzhen team leads it on site
- Where the fix is engineering rather than documentation, BOM Quote can carry the design, tooling, and test work
- Ongoing supplier oversight can continue as a monthly program
SCOPE YOUR DIAGNOSTIC
A short call establishes the device, the factory, the deadline, and whether this is the right starting point. You will get a written scope and fee before anyone commits.