Medical Device Machine Shops
Connect with ISO 13485 certified manufacturers specializing in medical devices and surgical instruments. FDA registered facilities with cleanroom capabilities and biocompatible material expertise.
Medical Manufacturing Capabilities
Precision & Cleanliness
- • ±0.0001" tolerances
- • 4 Ra surface finish
- • Class 7/8 cleanrooms
- • Validated cleaning processes
- • Contamination control
Specialized Processes
- • Electropolishing
- • Passivation (ASTM A967)
- • Laser marking (UDI)
- • Micro-machining
- • Swiss CNC for small parts
Quality & Compliance
- • ISO 13485 certified
- • FDA 21 CFR Part 820
- • Device History Records
- • Process validation (IQ/OQ/PQ)
- • Full traceability
Critical Medical Device Certifications
ISO 13485:2016
Medical device QMS
FDA Registered
21 CFR Part 820 compliant
ISO 9001:2015
Quality management
Cleanroom
ISO 14644 certified
Biocompatible Material Expertise
Titanium Alloys
Implants & instruments
- • Ti Grade 2 (CP Titanium)
- • Ti Grade 5 (Ti-6Al-4V)
- • Ti Grade 23 (Ti-6Al-4V ELI)
- • ASTM F136 compliant
Stainless Steels
Surgical instruments
- • 316L/316LVM
- • 17-4PH
- • 420/440C
- • ASTM F138 compliant
Specialty Alloys
Advanced applications
- • Cobalt Chrome (CoCr)
- • Nitinol (shape memory)
- • Tantalum
- • Platinum/Iridium
Medical Plastics
Device components
- • PEEK (implantable)
- • Delrin/Acetal
- • UHMWPE
- • Medical grade PTFE
Ceramics
Specialized implants
- • Zirconia
- • Alumina
- • Silicon Nitride
- • Bioactive glass
Absorbable Materials
Temporary implants
- • Magnesium alloys
- • PLA/PGA polymers
- • Calcium phosphates
- • Collagen composites
Medical Device Applications
Orthopedic Implants
- • Hip & knee replacements
- • Spinal implants
- • Bone screws & plates
- • Trauma fixation
Surgical Instruments
- • Forceps & scissors
- • Retractors & clamps
- • Endoscopic tools
- • Robotic surgery components
Cardiovascular
- • Stents & guides
- • Pacemaker components
- • Heart valve parts
- • Catheter components
Dental & Diagnostic
- • Dental implants
- • Orthodontic brackets
- • Diagnostic equipment parts
- • Lab equipment components
Medical Manufacturing FAQs
What certifications do medical device machine shops need?
Essential certifications include ISO 13485 (medical device quality management), FDA registration for Class II/III devices, ISO 9001, and often cleanroom certification (ISO 14644). Some also require biocompatibility testing per ISO 10993.
What materials are used for medical device manufacturing?
Common materials include titanium (Grade 2, Grade 5), stainless steel (316L, 17-4PH), PEEK, Delrin, cobalt chrome, nitinol for stents, and various biocompatible plastics. All materials must meet ASTM/ISO biocompatibility standards.
What are typical tolerances for medical components?
Medical device components typically require tolerances of ±0.0001" to ±0.0005". Surgical instruments and implants often demand even tighter tolerances with surface finishes as low as 4 Ra for reduced bacterial adhesion.
How do medical machine shops ensure sterility?
They maintain cleanroom environments (Class 7/8), use validated cleaning processes, implement contamination control procedures, and often provide passivation, electropolishing, or sterilization-ready packaging.
What validation is required for medical device manufacturing?
Process validation (IQ/OQ/PQ), design validation, equipment calibration, material certification, biocompatibility testing, and maintaining Device History Records (DHR) per FDA 21 CFR Part 820 requirements.
Connect with Medical Device Machine Shops
Get quotes from ISO 13485 certified shops with medical device expertise
Related Resources
Need help finding the right medical device machine shop? Contact us at support@machineshop.directory