Medical-device contract manufacturing

From first prototype to full production.

We build medical devices for the companies that design them. One partner, one quality system, every part on record.

Discuss your device program Request a manufacturing review

01/05

Design review

Send us your CAD. Our engineers flag anything that will be hard or costly to build, before you pay for tooling.

DFM review
Tolerance check
Material advice

Prototype

Working parts in days, in production-grade materials, so your test results still count later.

3D printing
CNC prototypes
Soft tooling

Pilot run

Small runs on the real process. We measure every feature, fix what drifts, then lock the process.

Process development
First-article inspection
IQ / OQ / PQ

Production

Machining, molding and cleanroom assembly at the volume you need, with every lot inspected.

Machining & molding
ISO 7 assembly
Volume capacity

Release

Packed, labeled and sterilized, then shipped with a complete device history record.

Sterile packaging
EO / gamma coordination
UDI labeling

A medical auto-injector shown as a wireframe CAD model

01 · CAD REVIEW

Scroll to build it

We make other companies' medical devices. To spec, on time, and on the record.

0years building
medical devices
0devices in
production today
0lots shipped
on time
0FDA 483 observations
in our last 3 audits

ISO 13485:2016certified quality system FDAregistered establishment 21 CFR 820QMSR compliant ISO 14644ISO 7 & ISO 8 cleanrooms ISO 11607validated sterile packaging ISO 14971risk management EU MDRtechnical file support

Services

Twelve services. Use one, or all of them.

Where is your device today?

All twelve, grouped by what they do.

Engineer it

01Design for manufacturing reviewWe find what will be hard, slow or costly to build, before tooling.

Written report with fixes, ranked by cost impact
Tolerance stack-up and material review
About 5 business days from files

02PrototypingWorking parts in days, in materials close to production.

SLA, SLS and CNC prototypes
Soft tooling for 50–500 molded parts
Same engineers carry the part into production

03Process development & validationWe design the process, then prove it runs the same every time.

Process FMEA and control plans
IQ, OQ and PQ protocols and reports
Capability studies (Cpk ≥ 1.33)

04Production transferMoving from another supplier or your own line, without a supply gap.

Transfer plan with a named lead
Bridge inventory while we qualify
Equivalence data for your regulatory file

Build it

05Precision machiningSwiss-type and 5-axis CNC, metals and plastics, to ±0.005 mm.

Titanium, stainless, cobalt-chrome, PEEK
Parts from Ø0.5 mm to Ø32 mm
Passivation, electropolish and laser marking

06Injection moldingMicro, liquid silicone and two-shot molding, with in-house tooling.

Cleanroom molding cells
Parts from 0.01 g
Tools built, owned by you, maintained by us

07Component productionSingle parts made to print and shipped to your line.

Kanban or scheduled releases
Certificate of conformance with every lot
Dual-source ready documentation

08Cleanroom assemblyManual and automated assembly in ISO 7 and ISO 8 cleanrooms.

Bonding, welding, crimping, coating
Semi-automated cells that scale with you
Operators trained and qualified per step

09Volume manufacturingCapacity planned a year ahead, so demand spikes don't become backorders.

Rolling 12-month capacity plan
Automated lines from 100k units a year
Monthly performance review

Check & ship it

10Inspection & testingCMM, vision, CT and functional tests, tied to every lot.

First-article reports for every new part
Inline vision checks on critical features
Leak, burst, pull and seal-strength testing

11Sterile packagingPouches, trays and cartons, sealed and validated to ISO 11607.

Packaging design and validation
UDI labels printed and verified
Seal strength tested per lot

12Sterilization coordinationWe manage EO, gamma or e-beam with qualified partners.

Cycle validation support
Chain of custody, both ways
Lots released to you with the paperwork done

Problems we fix

Four reasons teams call us.

“Our prototype works, but it’s hard to build.”

What we do: an engineering review of your design, then a pilot run on the real process. You see every change before it happens.

“We need to trust the quality and trace every part.”

What we do: inspection at every step, electronic batch records, and formal change control. Nothing changes without your sign-off.

“Demand is about to jump, and our supplier can’t keep up.”

What we do: a 12-month capacity plan, a named transfer lead, and bridge stock so supply never stops while we qualify.

“We can’t risk our design leaking.”

What we do: NDA before any files, a restricted project space only named people can open, and a code name for your project on the floor.

Quality & traceability

Every part has a paper trail.

Tap a part. That’s the record you’d get for it, for every device we ship.

The auto-injector taken apart: cap, needle shield, syringe, housing, plunger, spring and end cap

What you receive

First-article inspection reportEvery feature of every new part, measured.
Certificate of conformanceWith every lot we ship.
Device history recordMaterials, machines, people and results.
Validation reports (IQ / OQ / PQ)Proof the process is capable.
Material certificatesTraced back to the mill or resin lot.
Change noticesSent before a change, never after.

How we check

CMMto ±1.5 µm
Vision100% inline on critical features
CT scanhidden and internal features
Leak & burstevery lot, per spec
Pull & forcebonds, crimps, springs
Seal strengthASTM F88 on pouches

How changes happen

1Request
2Impact review
3Your sign-off
4Validate
5Release

Capabilities

What we build, and what we build it from.

Drug deliveryAuto-injectors, pens, inhaler parts
CardiovascularCatheter handles, hubs, introducers
OrthopedicImplant components, screws, instruments
SurgicalSingle-use instruments, handles, trocars
DiagnosticsCartridges, microfluidic chips, housings
WearablesPatch pumps, sensor housings, adhesives

Swiss-type CNCØ0.5–32 mm · ±0.005 mm
5-axis millingComplex implants and instruments
Micro moldingParts from 0.01 g
LSR moldingLiquid silicone seals and valves
Two-shot & overmoldingSoft grips, sealed housings
Laser weldingMetal and plastic joints
Ultrasonic weldingFast, clean plastic joints
UV bondingTubing, needles, catheters
Laser markingUDI and part IDs
Automated assemblyFrom 100k units a year
Pouch & tray sealingValidated to ISO 11607
Functional testingLeak, flow, force, electrical

Tap a material to see which sterilization methods it takes.

01PEEKPolyether ether ketone
02PCPolycarbonate
03COCCyclic olefin copolymer
04PPPolypropylene
05ABSAcrylonitrile butadiene styrene
06LSRLiquid silicone rubber
07TPUThermoplastic polyurethane
08PEBAPolyether block amide
09Ti64Titanium Ti-6Al-4V
10316LStainless steel
11NiTiNitinol
12CoCrCobalt-chromium

PlasticsElastomersMetalsEOGammaSteam

Technicians assembling devices in an ISO 7 cleanroom

Facility

42,000 sq ft. Built for medical work only.

3ISO 7 cleanrooms
1ISO 8 cleanroom
64CNC and molding cells
24/5production

Swiss-type lathe cutting a titanium bone screw — **Machining**Swiss-type and 5-axis cells

Robot removing clear micro-molded parts from a mold — **Molding**Cleanroom micro and LSR molding

CMM probe measuring a titanium implant part — **Metrology lab**Climate-controlled, 20 ±0.5 °C

Device being sealed into a sterile pouch — **Packaging**Validated sealing and labeling

Automated assembly machine — **Automation**Lines from 100k units a year

Certificate scope

“Contract design transfer, manufacture, assembly, inspection, packaging and sterilization management of medical devices and components.”

Certificate DM-13485-0917 · Valid to 2028-06-30 · Ask for a copy

Work we can show

We keep our clients’ names private. The results, we can share.

A cardiovascular company

Catheter handle, prototype to 40,000 a year in 11 months.

DFM
Molding
Assembly

Transfer

A spine company

Three suppliers down to one. Lead time from 14 weeks to 6.

Machining
Inspection
Transfer

A biologics company

Auto-injector sub-assembly scaled from 5k to 250k a year.

Assembly
Packaging
Sterilization

Straight answers

What buyers ask us first.

Ask us something else

Have you made parts like ours?

Probably. We have 140+ devices in production across drug delivery, cardiovascular, orthopedic, surgical and diagnostics. Send your drawings under NDA and we’ll show you similar work we’re allowed to share.

Can you support our stage of development?

Yes, from first CAD to full production. You can start with just a design review or a prototype run. No volume commitment needed.

What documentation will we receive?

A certificate of conformance and inspection data with every lot. A first-article report for every new part. IQ/OQ/PQ reports for validated processes. A device history record for every device.

Who owns the design and the tooling?

You do. Your design, your data and any tooling you pay for belong to you, in writing. If you ever move production, the tools and the documents go with you.

How do you protect our information?

We sign your NDA (or ours) before you send files. Your files sit in a restricted project space that only named team members can open, and your project gets a code name on the shop floor.

How fast can you start?

A manufacturing review takes about 5 business days from the day we get your files. Prototype parts usually ship in 1–3 weeks.

Start here

Tell us about your device.

Two minutes. An engineer, not a salesperson, replies within one business day.

Device type

Development stage

Processes you need pick any

Expected volume per year

10,000

Timing

Target markets

Name Work email Company

Send me an NDA firstWe’ll sign before you share any files.

Concept page: this form doesn’t send anything.