Medical Device Thermoforming RFQ | ISO 13485

Why Medical Device OEMs Choose DitaiPlastic

• ISO 13485-aligned quality system — document control, CAPA, design transfer, process validation, and supplier controls mapped to FDA 21 CFR Part 820.
• Full lot traceability — resin COA to finished device, recorded in DHR format compatible with your eQMS.
• Biocompatible material sourcing — ISO 10993-5/-10 tested resins from Covestro, Sabic, Kydex, and Röchling with manufacturer biocompatibility declarations.
• ISO 11607-compatible sterile packaging — thermoformed trays designed for gamma, EtO, and steam sterilization cycles.
• Validated processes on critical dimensions — IQ/OQ/PQ protocols delivered on request, with process capability (Cpk ≥1.33).

Current medical programs include a portable ultrasound housing, surgical instrument sterilization trays, IVD reagent cartridge covers, and a patient-bedside monitor enclosure. We work under MNDA from the first email and can provide redacted reference letters.

What You Get With Your Medical RFQ

• Free DFM review within 48 hours — flagging draft, wall uniformity, trim-line cleanliness for sterilization, and cleaning-fluid chemical compatibility.
• Biocompatible material recommendations — ISO 10993 test data, sterilization compatibility, chemical resistance to IPA, CaviWipes, hydrogen peroxide.
• Transparent cost breakdown — tooling, piece-part at your EAU, secondary ops (trim, drill, insert, assembly, cleanroom packaging).
• Timeline estimate aligned to your design freeze, verification build, and first commercial shipment.
• No obligation — DFM output is yours to keep.

Submit Your RFQ Start Your Medical RFQ

Typical Medical Projects We’ve Delivered

• Portable ultrasound housing — 4mm PC/ABS, IK07 impact, chemically resistant to CaviWipes/Super Sani-Cloth, 3,500 units/year across two SKUs.
• Surgical instrument sterilization tray — 3mm PETG, ISO 11607 validated for gamma 25 kGy and steam 134°C, 12,000 units/year.
• IVD reagent cartridge cover and light shroud — black FR-ABS with laser-welded light baffle, ±0.2mm critical dim, 8,000 units/year.
• Patient-monitor rear enclosure — 5mm Kydex 100, UL94 V-0, EN 60601-1 supporting mechanical, 6,000 units/year.

Volume ranges: 200 units (clinical trial builds) to 30,000 units/year (commercial production). We support both low-volume clinical and scaled commercial with the same tool or tool families.

Certifications & Compliance Supported

• ISO 9001:2015 and ISO 14001:2015 — certified.
• ISO 13485 — procedures aligned; formal certification on 2026 roadmap. Audited by customers today.
• FDA 21 CFR Part 820 — QSR-aligned design transfer, production controls, CAPA, supplier controls.
• ISO 10993-5 / -10 — cytotoxicity and sensitization-tested materials.
• ISO 11607-1/-2 — sterile barrier packaging design and validation support.
• IEC 60601-1 — mechanical/fire enclosure requirements supported via UL94 V-0 materials.
• REACH, RoHS, California Prop 65 — declarations on file.

Materials Best for Medical Devices

• Polycarbonate (PC) — transparent covers, instrument housings. ISO 10993 grades from Covestro Makrolon and Sabic Lexan. contact us
• PETG — sterilization trays, reagent covers. Gamma-compatible, crystal clear.
• Kydex — structural medical housings. UL94 V-0, excellent chemical resistance.
• Ultem (PEI) — autoclavable components. Repeated steam sterilization capable.
• FR-ABS — cost-effective enclosures. UL94 V-0, textured surface options.

What to Include in Your Medical RFQ

• CAD file — STEP, X_T, or IGES. PDF drawing with critical dimensions and GD&T.
• Annual volume and program life, including clinical vs commercial phase split.
• Material requirements — ISO 10993 class, sterilization method, cleaning agents.
• Regulatory context — FDA Class I/II/III, EU MDR classification, predicate device references.
• Critical dimensions and Cpk targets.
• Packaging requirements — sterile barrier, ESD, cleanroom bagging.
• Timeline — design freeze, V&V builds, first commercial shipment.

Accepted formats: .step / .stp / .x_t / .iges / .igs / .stl / .pdf / .dwg. NDA sent within 2 business hours of your request.

Response Time & Next Steps

Hour 0–2: NDA issued; engineer assigned.
Hour 0–8: Clarifying questions on regulatory and sterilization needs.
Hour 24–48: DFM review with material recommendation referencing ISO 10993 and 11607.
Day 5–10: Firm quote with tooling, piece-part, validation support scope.
Week 4–8: T1 samples off production tool; IQ/OQ protocol drafted; PPAP-equivalent submission.

Medical Device RFQ FAQ

Are you ISO 13485 certified?

Our quality procedures are ISO 13485-aligned and are audited annually by medical OEM customers. Formal certification is on our 2026 roadmap. ISO 9001:2015 and ISO 14001:2015 are currently certified.

Which sterilization methods do your parts support?

Gamma (25–40 kGy), EtO, steam autoclave (Ultem/PEEK only for repeated cycles), and hydrogen peroxide plasma. We’ll recommend the resin system based on your sterilization protocol.

Can you support IQ/OQ/PQ validation?

Yes. We provide validation protocol templates and execute under your protocol or ours, including DOE for critical parameters (oven temp, form pressure, cycle time) and capability studies (Cpk ≥1.33).

Do you operate a cleanroom?

We provide ISO Class 8-equivalent secondary operations (trim, clean, bag) in a controlled-environment room. For ISO Class 7/5 assembly we partner with a qualified downstream cleanroom.

How do you handle design changes during V&V?

Engineering change notices (ECN) per ISO 13485 document control, with impact assessment and re-validation scope before implementation.