Medical device quality and design control
QMSR and ISO 13485 gap analysis, design file structure, risk-to-verification traceability, and audit preparation for Class II electromechanical products.
Control what your Asian factory builds
AsianOPS helps U.S. medical device companies control outsourced product development and manufacturing in Asia. Our Shenzhen team verifies and implements at the factory what your quality records say should be happening.
The dangerous assumption
510(k)-exempt does not automatically mean QMSR-exempt, design-control-exempt, or supplier-control-exempt.
Exemption from premarket notification answers whether a 510(k) must be filed before marketing. FDA treats that separately from QMSR/CGMP exemptions and other regulatory controls. The device classification, product code, exemption limitations and operations each party performs determine which design, supplier, complaint and record requirements still apply. The dangerous assumption is that one exemption silently answers all of the others.
That gap widens when the product is made by someone else, in another country, under a different quality system, in a different language and time zone.
Six questions that decide your next audit
When manufacturing is outsourced, responsibilities follow the operations and authority each party actually holds.
We first determine who is acting as specification developer, manufacturer, contract manufacturer, relabeler, importer, labeler and complaint owner, then define which records each party must own, approve or be able to access.
- Who owns the design, and who is allowed to change it?
- Who maintains the design file, and where does it physically live?
- Who validated the manufacturing process, and against what acceptance criteria?
- Who approves critical suppliers and critical components?
- Who decides whether a deviation at the factory requires a CAPA?
- How does your U.S. team learn what changed on the line last month?
If several of those answers are unclear, or differ depending on who you ask, that is the problem we solve. It is also the problem that produces findings, because a divided process with no shared record leaves each party assuming the other one handled it.
From gap found to gap closed
Consultants identify gaps. Software tracks gaps. Closing a gap at a factory 7,000 miles away takes someone standing in it.
On-site implementation in Asia
Our Shenzhen team goes to the factory, verifies what is actually happening on the line, and leads remediation in the language and time zone where the work gets done.
Real engineering capability
Through BOM Quote, mechanical and electronic design, prototyping, tooling, PCBA and assembly, functional testing, and pilot builds, for when the fix is a design change rather than a document.
A shared record for both companies
The EquatorOps Platform gives the specification owner, the factory, and our team one working view of documents, requirements, gaps, and actions.
See the workspaceWho we typically work with
- Role
- U.S. specification developer, labeler, or brand owner
- Size
- Roughly 10 to 100 employees, one to ten active device families
- Product
- Class II home-use or noninvasive electromechanical devices
- Manufacturing
- Substantially outsourced to China or Southeast Asia
- Quality team
- Small, capable, and carrying more scope than headcount
When companies call us
- Moving an existing product to a new Asian factory
- A newly ISO 13485-certified factory building its first finished device
- Repositioning a consumer or wellness product as a medical device
- An FDA, ISO 13485, MDSAP, or customer audit inside the next six months
- Discovering a legacy product has no defensible design or risk file
- Changing a controller, sensor, firmware, heating element, power supply, material, claim, or critical supplier
- Bringing a private-label product under the brand owner's direct regulatory control
- A factory-designed device is being sold under your brand, but ownership of the design, labeling, complaints and change control has never been formally mapped
Five ways we work
Private-label and ODM programs often need role and file ownership mapped before the broader evidence diagnostic begins.
Private-label and ODM start here
Regulatory role & record ownership diagnostic
A fixed-scope first engagement for a factory-designed device, private-label arrangement, or any program where the legal roles, design authority and file boundary are not yet defensible.
Discuss this diagnosticWhat it maps
- Establishment-role map
- Design-authority map
- Labeling and UDI responsibility
- Complaint and MDR responsibility
- Device-listing responsibility
- File ownership and accessibility
- Shared/private record boundary
- Quality-agreement action list
Evidence baseline
QMSR diagnostic
A fixed-scope engagement that maps your evidence, finds the real gaps, and says who owns closing each one.
See the scope Moving productionDesign transfer
Qualify a new Asian manufacturer in the right order, so the evidence exists before the product ships.
How it runs Audit aheadAudit readiness
Preparation and remediation for FDA, ISO 13485, MDSAP, UL and customer audits, closed on site where needed.
What we cover OngoingManaged supplier quality
Monthly oversight, change monitoring and factory visits that keep the evidence true between audits.
See the programWe have done this before
- Class II
- Led the transfer of a flagship Class II device from in-house production to contract manufacturing in China
- Multi-year
- China supplier audit and quality program for a Class III medical device company
- 15+ years
- Operating in Asia since 2010, with our own Shenzhen NPI, QA and assembly facility
Medical device programs usually draw on the rest of what we do: on-site supplier audits, continuous FDA compliance monitoring, and engineering, tooling and pilot production through BOM Quote.
How an engagement runs
Every program starts with the smallest fixed-scope diagnostic that can establish roles, ownership and the real evidence gaps before you commit to a larger project.
- Step 1
Confirm the target
Audit or milestone scope, product status, regulatory roles, and who is accountable for what between you and the factory.
- Step 2
Build the evidence map
Inventory documents and executed records, separate procedures from evidence, and crosswalk your existing checklist to the current framework.
- Step 3
Close gaps in China
Verify implementation on site, lead remediation, and manage traceability, validation, manufacturing evidence, and corrective actions.
- Step 4
Prepare for the audit
Mock review, evidence request tracking, open-gap reporting, and an assembled evidence package for the auditor.
Start with a conversation
Tell us the product, the factory, and the deadline. We will tell you whether we can help and what it would take.