Medical Device Manufacturing

Parts your
regulatory affairs team
will actually approve.

Biocompatible Ti-6Al-4V ELI, PEEK, 316L, USP Class VI resins. Clean handling, passivated and electropolished surfaces, documented material traceability. ISO 13485-aligned workflow.

Medical RFQ QA consult

USP Class VI capable ISO 13485 workflow ISO 9001:2015 Cleanroom capable

01 · Medical applications

Where CIFProto parts ship in healthcare.

Surgical instruments

316L · electropolish

Hand-held surgical tools, retractors, forceps, bone plates. Passivated and electropolished to medical cosmetic standards.

Diagnostic housings

Al 6061 · anodize

IVD instrument enclosures, benchtop diagnostic chassis, portable health monitor housings. Anodized, EMI-gasketed.

Implant trial components

Ti Gr.23 ELI · PEEK

Pre-clinical implant trials, fitting cases, spine and orthopedic development prototypes. Not for terminal implantation.

Microfluidic chip frames

PMMA · COC · PEEK

Transparent manifolds, chip holders, PCR plate hardware. Optical-grade finishes on PMMA and COC.

Dental prototypes

SLA BioMed Clear

Dental aligner molds, surgical guides, crown and bridge trials. Class VI biocompatible resin, printed at 50 µm.

Medical robotics

7075 · 316L

Surgical robot arm brackets, end-effector housings, haptic feedback components. Weight-optimized.

Drug delivery

PEEK · 316L · silicone

Syringe driver housings, peristaltic pump components, inhaler trial parts, medical reservoir caps.

Wearable devices

Skin-contact materials

Biocompatible polymer enclosures for wearable sensors, pulse oximeters, continuous monitors. Ultrasonic welded.

Lab equipment

General-grade

Centrifuge rotors, analyzer chassis, pipette tips machined prototypes, lab automation fixtures.

02 · Medical materials

Biocompatible & medical-grade.

Metals

Ti-6Al-4V Gr.5

Osteoconductive, strong, lightweight. Standard implant alloy.

Ti-6Al-4V ELI Gr.23

Extra-low interstitial, improved fracture toughness for implants.

316L Stainless

Austenitic, non-magnetic. Surgical instruments, bone screws.

CoCrMo (F75)

Wear-resistant. Joint replacement bearings, dental frames.

Nitinol

Shape-memory NiTi. Guide wires, stents, orthodontic wires.

Polymers

PEEK

USP Class VI. High strength, steam autoclavable, long-term implant.

PEEK-CFR

Carbon-fiber reinforced PEEK. Structural load-bearing implant use.

Ultem 1010

USP Class VI PEI. Autoclavable 200+ cycles. Surgical tools.

Radel (PPSU)

Transparent, gamma sterilizable. Sterilization trays, fluid handling.

BioMed Clear SLA

USP Class VI resin. Short-term skin-contact, dental aligners.

FAQ

Medical manufacturing questions.

We operate under ISO 13485-aligned workflows including design controls, document control, non-conforming product handling, and CAPA procedures, but the formal ISO 13485 certificate is pending audit. For customers requiring certified suppliers, we partner with ISO 13485 certified subcontractors on specific project scopes. ISO 9001:2015 formally certified.

Metals: Ti-6Al-4V (Grade 5, Grade 23 ELI), 316L stainless steel, CoCrMo (cobalt chrome), Nitinol (shape memory). Polymers: PEEK (USP Class VI), PEEK-CFR (carbon reinforced), Ultem 1010 (USP Class VI), Radel (PPSU), medical-grade silicone, implantable PLA/PGA. Resins: Formlabs BioMed Clear (USP Class VI), Dental LT Clear (Class IIa).

Yes. We review and sign customer Quality Agreements (QAs), Supplier Quality Agreements (SQAs), and Product-Specific Quality Requirements. Typical review cycle 5–10 business days through our QA department. Our standard medical QA template is available on request.

Final cleaning, packaging and inspection of medical parts can be performed in our ISO 8 (Class 100,000) clean area. For more stringent environments (ISO 7 / Class 10,000 or better), we partner with certified medical contract manufacturers for the terminal cleaning and packaging steps.

316L passivation per ASTM A967, citric or nitric acid protocols, verified by copper sulfate test. Electropolishing for implantable stainless and Nitinol. Titanium anodizing (Type II decorative, Type III wear-resistant) — anodized colors for surgical instrument color coding. Glass bead blast for matte medical cosmetic. Ultrasonic cleaning, IPA rinse, HEPA-filtered drying.

Yes, for trial and development builds. Ti-6Al-4V ELI and PEEK implant prototypes are a regular workstream. For commercially distributed implants requiring regulatory-cleared suppliers, we work alongside customer-nominated sterilization and final-packaging partners. We do not perform terminal sterilization in-house.

Materials we work with carry standard biocompatibility qualifications. PEEK, Ultem 1010, BioMed Clear resin: USP Class VI tested. Ti Grade 23, CoCr: ISO 10993-5 cytotoxicity and ISO 10993-10 sensitization verified by mill. Final device biocompatibility testing remains the customer's responsibility per ISO 10993 series.

Parts yourregulatory affairs teamwill actually approve.