Medical
Biocompatible materials, ISO 13485-quality systems, and mission-critical precision for life-saving medical devices.Learn more here.
Overview
Medical device manufacturing leaves no room for error. The components we machine may be implanted in patients or used in critical surgical procedures.
Capabilities
Orthopedic implants, dental implants and abutments, cardiovascular devices with ultra-fine finishes.
Surface finishes to Ra 0.2 μm (8 μin), biocompatible processing
Cutting and grasping tools, retractors and spreaders, minimally invasive instruments.
Passivation per ASTM A967, laser marking UDI compliant
Analyzer components and manifolds, precision fluidic channels, sensor housings.
Cleanroom-compatible packaging available
Features down to 0.1mm, micro-fluidic devices, miniature connectors.
High-magnification inspection, CMM with micro-probes
Design validation prototypes, clinical trial manufacturing, production scale-up.
2-week lead time, expedite for clinical needs
Certifications & Quality Standards
| Certification | Status | Scope |
|---|---|---|
| ISO 13485 | Target | Medical Device Quality Management |
| ISO 9001:2015 | Current | General Quality Management |
| FDA Registration | Planned | US Medical Device Manufacturing |
| MDSAP | Target | Medical Device Single Audit Program |
Quality Processes
- Design History File (DHF) documentation support
- Device Master Record (DMR) and Device History Record (DHR)
- Risk Management per ISO 14971
- Biocompatibility documentation (ISO 10993)
- Unique Device Identification (UDI) marking
- Sterilization validation support
- CAPA (Corrective and Preventive Action) system
Materials We Work With
| Material | Grades | Applications | Notes |
|---|---|---|---|
| Titanium | Ti-6Al-4V ELI, Ti-6Al-7Nb, CP Ti | Implants, instruments, dental | Biocompatible, osseointegration, MRI-safe |
| Stainless Steel | 316LVM, 17-4PH, 420, 440C | Instruments, implants, hardware | Corrosion resistant, sterilizable, hardenable |
| Cobalt Chrome | ASTM F75, F799, F1537 | Joint replacements, dental | Wear resistant, biocompatible, high strength |
| PEEK | Medical grade, implantable | Spinal implants, orthopedic | Radiolucent, biocompatible, sterilizable |
| Plastics | PPSU, PSU, POM (Delrin) | Instrument handles, housings | Autoclavable, chemical resistant |
| Exotics | Nitinol, Tantalum, Platinum | Stents, markers, electrodes | Shape memory, radiopaque, inert |
Applications We Serve
Orthopedics
- Hip and knee replacement components
- Spinal fusion cages and screws
- Trauma plates and screws
- External fixation devices
Surgical Instruments
- General surgery tools (forceps, clamps, scissors)
- Orthopedic instruments (drills, reamers, drivers)
- Minimally invasive laparoscopic tools
- Robotic surgery components
Cardiovascular
- Pacemaker and ICD housings
- Vascular stent components
- Heart valve components
- Catheter and delivery system parts
Diagnostic & Laboratory
- PCR machine components
- Blood analyzer manifolds
- Microscope stages and mounts
- Imaging equipment hardware
Drug Delivery
- Pen injector components
- Infusion pump parts
- Inhaler mechanisms
- Wearable delivery devices
Case Study Highlights
Spinal Implant Production
Client: Medical Device Company (Orthopedics)
Produce titanium spinal screws with complex thread profile and precise hex drive, requiring consistent quality for implantation.
Developed dedicated tooling and inspection fixtures, implemented 100% dimensional inspection with automated CMM routines.
99.8% first-pass yield, zero field failures, awarded preferred supplier status, annual volume 50,000+ units.
Micro-Fluidic Diagnostic Component
Client: Point-of-Care Diagnostics Company
Machine micro-fluidic channels (0.2mm width) in plastic manifold for blood analysis device, requiring burr-free edges and tight tolerances.
Micro-machining with specialized tooling and techniques, developed custom deburring process for clean channels.
Channels passed fluid flow validation, component successfully integrated into FDA-cleared diagnostic device.
Project Gallery
Why Choose PiPrecision
- Patient-Safety Mindset: Every component we machine could impact a patient's life. Our processes, training, and culture reflect this responsibility.
- Biocompatibility Expertise: We understand the unique requirements of medical materials—how to machine them, finish them, and handle them to maintain biocompatibility.
- Regulatory Support: Documentation, traceability, and quality systems designed to support your FDA submissions and regulatory audits.
- Rapid Prototyping: Fast turnaround on prototypes helps you iterate designs and meet aggressive product development timelines.
- Scalable Quality: The same rigorous quality whether we're making 10 prototypes or 10,000 production units. Consistency you can count on.
Lead Times
| Prototype | 2 weeks |
| Production | 2-3 weeks |
| Expedite | 1 week |