Medical Manufacturing
ISO 13485:2016 Certified — Trusted by Medical Device Makers, Wearable Technology Startups, and Research Institutions — From First Prototype to Production-Grade Device Components.
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Medical Manufacturing from Prototype to Production for New Product Development
CipherFab's Digital Manufacturing platform has an endless combination of processes, finishes, and materials.
CNC Machining
5-axis CNC milling, CNC turning, Swiss lathe micro-machining, and Wire EDM for surgical instruments, implants, and device components; tolerances to ±0.0025 mm on critical features; materials include titanium Ti-6Al-4V, stainless 316L and 17-4PH, cobalt-chrome, PEEK, Ultem, Delrin, Radel, and PSU
3D Printing
SLA and FDM in sterilisable biocompatible resins (Ultem, ABS M30i, PPSF) for functional device prototypes and surgical models; DMLS in titanium and 316L stainless for patient-specific implant geometries and complex internal features; MJF for high-strength polymer device housings
Injection Moulding
ISO 13485-certified moulding in medical-grade ABS, PP, PEEK, LSR, TPE, and Ultem; overmoulding and insert moulding available; full DFM review, PPAP, IQ/OQ/PQ, and production control plans on every programme; cleanroom moulding in ISO 7 and ISO 8 environments available
Sheet Metal Fabrication
Stainless steel and aluminium enclosures, chassis, and structural panels for diagnostic equipment, capital medical equipment, and laboratory instrumentation; electropolishing and passivation available for sterile-field applications
ISO 13485:2016 Certified — Trusted by Medical Device Makers, Wearable Technology Startups, and Research Institutions — From First Prototype to Production-Grade Device Components.
CipherFAB works with medical device manufacturers, wearable technology companies, 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 biocompatibility documentation, cleanroom-compatible manufacturing, and expert DFM review on every order.
What We Manufacture
- Surgical Instruments & Tools Scalpels, forceps, clamps, retractors, needle drivers, and laparoscopic instrument components — machined in stainless steel 316L and 17-4PH and titanium Ti-6Al-4V using 5-axis CNC milling and Swiss lathe; burr-free edges, pass
- Implantable Device Components Orthopaedic implants, bone screws, spinal cages, joint replacement components, and fixation plates — precision-machined in titanium Ti-6Al-4V, cobalt-chrome, and PEEK; tolerances to ±0.0025 mm on critical features; full bioco
- Diagnostic & Imaging Equipment Components Housings, structural brackets, sensor mounts, manifolds, pump bodies, and valve components for diagnostic imaging systems, in-vitro diagnostic equipment, and laboratory instrumentation — CNC machined and sheet met
- Wearable Medical Technology Enclosures, structural frames, and precision components for wearable monitoring devices, patient-worn sensors, and portable diagnostic equipment — CNC machined and 3D-printed in medical-grade PEEK, Ultem, and aluminium
- Prosthetics & Orthotics Structural components and custom-geometry hardware for prosthetic limbs, orthotic devices, and exoskeleton assemblies — machined in titanium and aluminium with DMLS available for complex internal geometries and patient-specific des
- Surgical Models & Research Fixtures Anatomical models, surgical simulation components, and custom research fixtures — 3D-printed in biocompatible resins via SLA and FDM for pre-operative planning, training, and laboratory research applications
- High-Volume Device Component Production ISO 13485-certified injection moulding for housings, covers, connectors, and device sub-assemblies in medical-grade ABS, polypropylene, PEEK, LSR, TPE, and Ultem — from prototype tooling through serialised productio
Quality Assurance
Every medical order on CipherFab includes:
- Certificates of Conformance and material certifications as standard
- Full material and process lot traceability across all metallic and polymer components — 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
- Custom sampling plans and production control plans for serialised device production
- Cleanroom manufacturing in ISO 7 and ISO 8 controlled environments with cleanroom-compatible packaging, desiccant, anti-static liners, and lot/serial identification for Device History
- Records (DHR) Passivation, electropolishing, and validated ultrasonic cleaning available for sterile-field and implant-grade components
- DFM review on every uploaded file — geometry, wall thickness, tolerances, material biocompatibility, and sterilisation compatibility reviewed before production begins
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.
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