Medical Manufacturing
ISO 13485:2016 Certified — Trusted by Medical Device Makers, Wearable Technology Startups, OEM Suppliers, and Research Institutions — From First Prototype to Production-Grade Device Components.
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Medical Manufacturing from First Prototype to Production-Grade Device Components
ISO 13485:2016-certified CNC machining, 3D printing, injection moulding, and sheet metal with biocompatibility documentation on every order.
CNC Machining
3D Printing
Injection Moulding
Sheet Metal Fabrication
ISO 13485:2016 Certified — Trusted by Medical Device Makers, Wearable Technology Startups, OEM Suppliers, and Research Institutions — From First Prototype to Production-Grade Device Components.
CipherFab works with medical device manufacturers, wearable technology companies, contract manufacturers, and research institutions to accelerate rapid prototyping and dynamically scale manufacturing capacity. Our ISO 13485:2016-certified platform gives engineering and regulatory teams instant access to CNC machining, 3D printing, injection moulding, and sheet metal fabrication — with full material traceability, biocompatibility documentation, cleanroom-compatible manufacturing, and expert engineering review on every order.
What We Manufacture
- Surgical Instruments & Tools — Scalpels, forceps, clamps, retractors, needle drivers, and laparoscopic components in 316L, 17-4PH, and titanium Ti-6Al-4V; passivation and electropolishing to Ra ≤ 0.4 µm
- Implantable Device Components — Orthopaedic implants, bone screws, spinal cages, joint replacements, and fixation plates in titanium, cobalt-chrome, and PEEK with full biocompatibility documentation
- Diagnostic & Imaging Equipment Components — Housings, brackets, sensor mounts, manifolds, pump bodies, and valve components for diagnostic imaging and laboratory instrumentation
- Wearable Medical Technology — Enclosures, frames, and precision components for wearable monitoring and portable diagnostic equipment in medical-grade PEEK, Ultem, and aluminium
- Prosthetics & Orthotics — Structural components and custom-geometry hardware with DMLS for complex internal geometries and patient-specific designs
- Surgical Models & Research Fixtures — Anatomical models and fixtures via SLA and FDM for pre-operative planning, training, and laboratory research
- High-Volume Device Component Production — ISO 13485-certified injection moulding for housings, covers, connectors, and sub-assemblies with PPAP, IQ/OQ/PQ, and production control plans
Manufacturing Capabilities
- CNC Machining — 5-axis milling, turning, Swiss lathe micro-machining, and Wire EDM; tolerances to ±0.0025 mm; titanium Ti-6Al-4V, 316L, 17-4PH, cobalt-chrome, PEEK, Ultem, Delrin, Radel, and PSU
- 3D Printing — SLA and FDM in sterilisable biocompatible resins; DMLS in titanium and 316L for patient-specific implants; MJF for high-strength polymer housings
- Injection Moulding — ISO 13485-certified moulding in medical-grade ABS, PP, PEEK, LSR, TPE, and Ultem; overmoulding and insert moulding; cleanroom moulding in ISO 7 and ISO 8 available
- Sheet Metal Fabrication — Stainless and aluminium enclosures and structural panels for capital medical equipment; electropolishing and passivation for sterile-field applications
Quality Assurance
Every medical order on CipherFab includes:
- Certificates of Conformance and material certifications as standard
- Full material and process lot traceability from incoming raw material inspection through final shipment
- CMM inspection and full dimensional reports on request; Cpk ≥ 1.67 on critical-to-quality features available for serialised production
- First Article Inspection (FAI) for new device builds and production tooling qualification
- PPAP and IQ/OQ/PQ documentation for new programme launches and engineering changes
- Cleanroom manufacturing in ISO 7 and ISO 8 with cleanroom-compatible packaging for Device History Records (DHR)
- Passivation, electropolishing, and validated ultrasonic cleaning for sterile-field and implant-grade components
- DFM review on every uploaded file — geometry, wall thickness, tolerances, biocompatibility, and sterilisation compatibility reviewed before production begins
Certifications & Compliance
- ISO 13485:2016 — Medical device quality management system covering design, development, production, installation, and servicing
- ISO 9001:2015 — General quality management system across all manufacturing processes
- ITAR Registered — For medical technology with dual-use or export control classification
- FDA Compliance Support — FAI, custom sampling plans, PPAP, IQ/OQ/PQ, and production control plans for 510(k) and PMA audit requirements
- ISO 7 & ISO 8 Cleanroom Manufacturing — Controlled-environment production with cleanroom-compatible packaging
- UL Certification — Available for electrical and electronic medical device components requiring UL compliance
- Material Certifications — Full biocompatibility documentation, CoA, and lot-level traceability from raw material through shipment
Why CipherFab for Medical
Medical device manufacturing operates at the intersection of engineering precision and patient safety. A missed tolerance, an undocumented material change, or a gap in lot traceability is not just a quality failure — it is a regulatory and clinical risk. Finding a manufacturing partner who understands both the engineering demands of implantable and sterile-field components and the documentation rigour of ISO 13485, FDA QSR, and EU MDR is the challenge every medical device team faces. CipherFab consolidates CNC machining, additive manufacturing, injection moulding, and sheet metal fabrication under one ISO 13485:2016-certified platform and one point of contact — with full traceability, cleanroom access, and regulatory documentation built into every order. Whether you are producing first-article prototypes for a 510(k) submission, sourcing a complex subassembly for an investigational device, or scaling a Class II device into production, CipherFab gives your programme team the precision, compliance infrastructure, and turnaround speed that medical device development demands.