Medical device contract manufacturing.
Under your regulatory framework.
Cleanroom assembly, packaging, sub-assembly, testing, and depot repair for non-implantable medical devices — under your ISO 13485 / FDA QSR / 21 CFR 820 framework. 20,000+ sq. ft. ISO Class 6 and Class 7 cleanroom in Canton, Michigan, USA. ISO 9001 + 14001 certified, NMSDC MBE.
Cleanroom Capacity for OEMs Who Own the QMS.
Most medical device contract manufacturers package the entire regulated stack — ISO 13485, validation, FDA filings — and want to own the QMS. For OEMs who already own that framework and just need cleanroom assembly capacity inside it, the market is thin.
You Own ISO 13485. You Need Cleanroom Capacity.
When you run your own ISO 13485 QMS, you need cleanroom capacity for surge, ramp, or specific assembly steps — without rebuilding your audit chain through a competing-QMS partner. Most CMs package their own QMS into the deal, adding audit complexity to your FDA file.
Class I and Non-Implantable Programs Are Underserved
Much of medical device manufacturing is Class I or non-implantable — DME, diagnostic devices, home monitoring, instrument sub-assemblies. Programs that don't need ISO 13485 but do need cleanroom assembly get squeezed out of bids that grade every vendor as if it were Class III implantable.
Pre-Cert? You Need Production Now.
Pre-launch, you have ISO 13485 framework on paper but no physical cleanroom yet. Bridging from pilot to first commercial run inside a partner's facility is a common path — it requires a CM that can operate cleanly under your framework. Lotus does.
Cleanroom Capacity. Your QMS.
No Conflict.
Lotus runs medical device contract manufacturing under your regulatory framework. Your ISO 13485, FDA QSR, DHF, validation protocols — Lotus is the production partner inside that framework, not the owner. 20,000+ sq. ft. of ISO Class 6 and Class 7 cleanroom is ready to run your assembly, packaging, and testing programs without adding QMS audit overhead.
Our Canton facility is ISO 9001:2015 and ISO 14001:2015 certified — not ISO 13485. That is the model, not a gap. If you need cleanroom capacity without the parallel-QMS overhead, this is the arrangement.
- 20,000+ sq. ft. ISO Class 6 + ISO Class 7 cleanroom (Class 1,000 + Class 10,000)
- Assembly performed under your ISO 13485 / FDA QSR / 21 CFR 820 framework
- Non-implantable scope: DME, diagnostic equipment, home monitoring, sub-assemblies, life-sciences packaging
- Same-facility depot repair, RMA, and asset recovery for medical devices
- ISO 9001 + 14001 certified, NMSDC MBE — fits supplier-diversity bids
From Sub-Assembly to Field Returns.
Cleanroom sub-assembly, final assembly, packaging, functional testing, distribution, and depot repair — all from one Canton, Michigan, USA facility, under your regulatory framework.
Cleanroom Sub-Assembly
Component-level sub-assembly in ISO Class 6 or Class 7, with gowning protocols, particulate monitoring, and full lot traceability — under your QMS.
Final Assembly & Integration
Multi-part device integration in cleanroom or controlled-environment workstations, with calibrated measurement and documented inspection at every stage.
Functional Testing & Validation
In-process inspection, end-of-line functional test, and validation runs against your acceptance criteria. Test data and DHR documentation in your format.
Cleanroom Packaging
Cleanroom packaging, labeling, UDI marking, and final-product configuration — same gowning and contamination-control discipline as assembly. Sterile-fill is out of scope.
Distribution & Direct-Ship
Same-building 3PL with cold-chain support, OEM-spec packaging, routing-guide compliance, and 12 truck wells for staged deployments.
Depot Repair, RMA & Asset Recovery
Returned devices route to Canton for component-level diagnosis, repair, refurbishment, and RMA processing under ISO 9001:2015. The team that assembled them handles the repair.
Inside the Midwest Medical Corridor.
The Midwest hosts a meaningful slice of the US medical device industry — Stryker in Kalamazoo, Medtronic across the upper Midwest, plus mid-cap diagnostic, DME, and home-monitoring OEMs. Canton, Michigan, USA sits in that corridor, within trucking distance of your engineering team, suppliers, and distribution hubs.
If you run an ISO 13485 program and need a cleanroom partner inside your framework — no parallel-QMS overhead, no supply-chain miles — location matters. Backed by cleanroom operations and reverse logistics.
- Canton, Michigan, USA — Midwest medical device corridor
- 20,000+ sq. ft. ISO Class 6 + 7 cleanroom under your QMS
- Non-implantable medical device assembly + packaging
- Same-facility depot repair, RMA, and asset recovery
- ISO 9001 + 14001 + NMSDC MBE — fits supplier diversity bids
Years Manufacturing
Sq. Ft. Cleanroom
ISO Cleanroom Classes
Medical device programs need three things most CMs can't offer at once: cleanroom capacity, freedom from competing-QMS overhead, and US depot repair under one roof. Lotus is built for OEMs who own ISO 13485 and need a partner inside it.
Cleanroom assembly. Depot repair. Your QMS, our facility.
Cleanroom capacity without competing QMS
20,000+ sq. ft. ISO Class 6 and Class 7 cleanroom, operated under our ISO 9001 + 14001 system. Assembly programs run under your framework — no parallel-QMS audit overhead on your FDA file.
Clear scope on what we do and do not do
Lotus is not ISO 13485 certified. No sterile-fill, no implantable assembly. We do cleanroom assembly, packaging, sub-assembly, testing, and depot repair for non-implantable devices under your QMS.
Lifecycle services in the same building
Cleanroom assembly + reverse logistics + depot repair + asset recovery, all from one Canton, Michigan, USA facility. Devices returning from the field route back to the team that assembled them.
When it comes to manufacturing products, they don't mess around. They've been nothing but professional with the highest emphasis on quality. Lotus took the time to get to the root of any problems and correct them once and for all.
Lotus has provided us with a unique personalized support system that continuously adapts to our business needs. Through its standardized processes, state-of-the-art facility, and systems, Lotus has excelled in providing our customers with great support.
Explore the Capabilities Behind the Program
Cleanroom Operations
20,000+ sq. ft. ISO Class 6 and Class 7 cleanroom for medical device assembly, packaging, and testing — under your regulatory framework.
ExploreReverse Logistics & Depot Repair
Depot repair, RMA processing, and asset recovery for field-returned medical devices. Component-level repair under ISO 9001.
Explore3PL Warehousing & Distribution
Same-facility 3PL with cold-chain support, configure-to-order, drop-ship, and forward + reverse logistics for medical device programs.
ExploreMedical Device Contract Manufacturing FAQ
Medical device contract manufacturing outsources production, assembly, packaging, or testing to a third-party CM that builds to your specs under your regulatory framework. The CM provides the facility, cleanroom, equipment, and labor; you provide the design, BOM, regulatory ownership, and brand. Lotus runs assembly, sub-assembly, packaging, and testing under your QMS in 20,000+ sq. ft. of ISO Class 6 and Class 7 cleanroom.
No. Lotus is ISO 9001:2015 and ISO 14001:2015 certified — not ISO 13485. We support medical programs by running assembly, testing, and packaging under your framework. Your ISO 13485 / FDA QSR / 21 CFR 820 governs the program; Lotus is the production partner inside it. If you need a contamination-controlled partner without rebuilding your QMS audit trail, this is the standard arrangement.
Cleanroom assembly, testing, and packaging for non-implantable medical devices and components — diagnostic equipment, home monitoring, DME, instrument sub-assemblies, and life-sciences packaging — under your regulatory framework. Implantable devices, sterile-fill, and work requiring our own ISO 13485 are out of scope.
Both ISO Class 7 (Class 10,000) and ISO Class 6 (Class 1,000) across 20,000+ sq. ft. — validated for particulate control, temperature, and humidity. Specify which class your assembly steps require; we can mix classes within a single program when your process flow needs it.
Yes. Cleanroom packaging, labeling, and final-product configuration for medical devices, with the same gowning and contamination-control discipline as our assembly operations. Sterile-fill is out of scope.
Yes. Our reverse logistics and depot repair handles RMA processing, component-level repair, refurbishment, and asset recovery for medical programs. Returned units route to Canton, Michigan, USA for diagnosis and repair under ISO 9001:2015 — integrated with the assembly programs we run for you.
Full lot, batch, and serialized component traceability through our ISO 9001 system, with calibrated measurement traceable to national standards, documented inspection at every stage, and a client portal for production data. DHR documentation, validation protocols, and FDA artifacts are produced to your templates under your QMS.
All medical device assembly happens in our 300,000 sq. ft. Canton, Michigan, USA facility — domestic, single-site, MBE-certified. The Midwest medical-device corridor (Stryker in Kalamazoo, Medtronic across the upper Midwest, mid-cap diagnostic and DME OEMs) sits within trucking distance — useful for site visits, audits, and rapid-iteration programs.
Ready to talk medical device contract manufacturing?
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