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.
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.
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Device and regulatory-role map
Product classification, applicable requirements, and which regulated role each party actually occupies: specification developer, contract manufacturer, importer, labeler.
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Audit and milestone scope confirmation
What the upcoming audit or milestone will actually cover, so remediation effort goes where it will be examined.
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Existing-document and executed-record inventory
Everything that exists today, classified and, critically, separated into controlled procedures versus executed records.
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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.
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Design file evidence map
Design History File and Medical Device File / Device Master Record structure, showing which records fill which section and which sections are empty.
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Requirement-to-document gap matrix
Each applicable requirement traced to the evidence that satisfies it, or flagged where nothing does.
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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?
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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.
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Prioritized 30/60/90-day remediation plan
Ordered by regulatory exposure and deadline, with the work that requires factory presence identified separately.
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Leadership readout
A briefing your executives and board can act on, in language that does not require a quality background.
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 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.