Medical Device OEM Manufacturing
Specialized manufacturing for medical device OEMs with ISO 13485 certification, biocompatible materials, and regulatory compliance. From surgical instruments to implantable devices - delivered with precision and speed.
Why Medical Device OEMs Choose MakerStage
Our specialized medical manufacturing facility combines regulatory compliance, quality assurance, and rapid turnaround for medical device development.
ISO 13485 Certified
Quality management system specifically for medical devices
Biocompatible Materials
USP Class VI, biocompatible materials with full traceability
Rapid Prototyping
3-7 day turnaround for medical device prototypes
Regulatory Documentation
Complete documentation packages for regulatory submissions
Medical Device Manufacturing Capabilities
Specialized processes and materials for medical device components, from prototypes to production runs with full regulatory compliance.
Medical CNC Machining
Biocompatible Materials
Medical Specifications
±0.0002" achievable
3-5 days (prototypes)
ISO Class 7
Gamma, EtO compatible
Medical Materials
Medical Applications
- Surgical instrument components
- Implantable device housings
- Diagnostic equipment parts
- Medical testing fixtures
Medical 3D Printing
Biocompatible Materials
Medical Specifications
25µm (SLA)
1-3 days
Autoclave compatible
USP Class VI certified
Medical Materials
Medical Applications
- Surgical guides and templates
- Anatomical models for planning
- Custom prosthetic components
- Medical device prototypes
Medical Injection Molding
High-Volume Production
Medical Specifications
3-5 weeks
1-2 weeks
1,000 pieces
ISO Class 8
Medical Materials
Medical Applications
- Disposable medical components
- Syringe and catheter components
- Drug delivery device parts
- Medical housing components
Medical Assembly & Packaging
Sterile Processing
Medical Specifications
ISO Class 7 Cleanroom
Gamma, EtO, Autoclave
Sterile barrier systems
IQ/OQ/PQ protocols
Services
Medical Applications
- Complete device assembly
- Sterile packaging solutions
- Medical device kitting
- Regulatory compliant labeling
Regulatory Compliance & Quality Assurance
Our medical manufacturing facility maintains the highest standards for regulatory compliance and quality management systems.
ISO 13485:2016
Quality management systems for medical devices with full documentation and traceability.
- Document control
- Design controls
- CAPA system
- Management review
Quality Management
Comprehensive quality system controls for medical device manufacturing.
- Design controls
- Production controls
- CAPA
- Device history records
Material Certifications
Complete material traceability with certificates for medical applications.
- USP Class VI
- ISO 10993
- Material data sheets
- Mill test certificates
Medical Device Applications
We manufacture components for a wide range of medical devices, from surgical instruments to diagnostic equipment.
Surgical Instruments
Operating room tools requiring precision and biocompatibility
- Laparoscopic instrument handles
- Surgical cutting tools
- Endoscopic components
- Orthopedic implant tools
Diagnostic Equipment
Medical diagnostic systems requiring high precision and reliability
- Imaging device components
- Laboratory instrument parts
- Blood analysis system parts
- Diagnostic test fixtures
Therapeutic Devices
Patient treatment devices requiring biocompatible materials
- Drug delivery system components
- Catheter and tube components
- Prosthetic device parts
- Rehabilitation equipment
Implantable Devices
Long-term implantable devices requiring USP Class VI materials
- Orthopedic implant components
- Cardiovascular device parts
- Dental implant components
- Neurostimulator housings
Monitoring Equipment
Patient monitoring systems requiring EMI shielding and durability
- Patient monitor housings
- Sensor mounting components
- Display bezels and controls
- Cable and connector parts
Laboratory Equipment
Lab equipment requiring chemical resistance and precision
- Analytical instrument parts
- Sample handling components
- Microfluidic devices
- Laboratory automation parts
Medical Device Manufacturing FAQ
Common questions from medical device OEMs about our manufacturing capabilities.
What certifications do you have for medical device manufacturing?
We maintain ISO 13485:2016 certification for medical device quality management systems and comprehensive quality controls. Our facility operates under ISO Class 7 and 8 cleanroom standards depending on the application.
Which materials are biocompatible and certified?
We stock USP Class VI certified materials including medical grade PEEK, Ultem, titanium alloys (Grade 2 and 5), stainless steel 316L, and various medical grade plastics. All materials come with full traceability documentation.
What documentation do you provide for regulatory submissions?
We provide comprehensive documentation packages including material certifications, dimensional inspection reports, process validation documents, biocompatibility test reports, and sterilization validation data for regulatory submissions.
Can you handle prototyping and low-volume production?
Yes, we specialize in rapid prototyping (1-5 days) for design validation and can scale to low-volume production (10-1000 pieces) while maintaining full regulatory compliance and traceability.
What sterilization methods are your parts compatible with?
Our medical parts are designed to be compatible with gamma radiation, ethylene oxide (EtO), and steam autoclave sterilization methods. We can provide sterilization validation data and recommend optimal methods based on material selection.
Do you offer assembly and packaging services?
Yes, we provide sterile assembly services in ISO Class 7 cleanrooms, sterile barrier system packaging, serialization, labeling, and complete supply chain management for finished medical devices.
Ready to Start Your Medical Device Project?
Get a quote for your medical device manufacturing needs with full regulatory compliance and expert engineering support.