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.
510(k)-exempt does not mean QMSR-exempt, design-control-exempt, or supplier-control-exempt.
Exemption from premarket notification is a decision about whether you file before you sell. It is not a decision about whether you need design controls, a design file, process validation, or supplier oversight. Plenty of Class II devices never require a submission and still require the entire quality system behind them. Companies usually discover the difference when an auditor asks for records nobody has been keeping.
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, responsibility is divided but accountability is not. You remain responsible for the finished device.
- 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.
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.
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
EquatorOps gives the specification owner, the factory, and our team one working view of documents, requirements, gaps, and actions. See the workspace ›
Who we 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
WE HAVE DONE THIS BEFORE
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 a fixed-scope diagnostic, so you get a defined answer before committing to a larger project.
Confirm the target
Audit or milestone scope, product status, regulatory roles, and who is accountable for what between you and the factory.
Build the evidence map
Inventory documents and executed records, separate procedures from evidence, and crosswalk your existing checklist to the current framework.
Close gaps in China
Verify implementation on site, lead remediation, and manage traceability, validation, manufacturing evidence, and corrective actions.
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.