Medical Device OEM Manufacturing
Specialized manufacturing for medical device OEMs. We work with ISO 13485 certified suppliers in our network (certification varies by supplier), 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 Partners
We route to suppliers with medical device QMS certification when required
Biocompatible Materials
USP Class VI, biocompatible materials with full traceability
Rapid Prototyping
Fast 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
As tight as ±0.0002"
Typically 10-15 days
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)
1–5 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 (partners)
We route to partners with medical device QMS certification; 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?
MakerStage is not ISO certified. Our supplier network includes ISO 13485:2016 certified facilities—not all suppliers are certified. When you need certified medical device QMS or ISO Class 7/8 cleanrooms, we route your project to a qualified facility.
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 work with partners that provide sterile assembly in ISO Class 7 cleanrooms, sterile barrier system packaging, serialization, labeling, and supply chain management for finished medical devices.
What is medical component manufacturing?
Medical component manufacturing is the production of parts and subassemblies for medical devices under a quality management system (typically ISO 13485). It covers CNC machining, 3D printing, and finishing of biocompatible materials (USP Class VI plastics, titanium, 316L stainless steel) with full traceability, material certs (MTRs), and documentation suitable for regulatory submissions. MakerStage routes medical component manufacturing to ISO 13485 certified partners in our network when certification is required.
Where can I get custom medical parts made?
Custom medical parts require a supplier that offers biocompatible materials, tight tolerances (±0.005 in. / ±0.13 mm typical), and regulatory documentation. MakerStage provides custom medical parts via CNC machining and 3D printing through partners with ISO 13485 certified QMS where required. Materials include PEEK (USP Class VI), Ultem, titanium Grade 2 and 5, 316L stainless steel, and medical-grade nylons. Typical lead time is 10–15 business days with full traceability and documentation packages.
What are medical precision parts?
Medical precision parts are components for medical devices that require tight dimensional tolerances (often ±0.001 in. / ±0.025 mm or finer), controlled surface finish (Ra per ISO 4287), and material traceability. Applications include surgical instrument components, implantable device housings, diagnostic device optics mounts, and fluid-handling parts. Manufacturing typically uses CNC machining or precision 3D printing (e.g., DMLS for metal) with CMM inspection and documentation suitable for FDA 21 CFR 820 and ISO 13485 design controls.
What does a medical device OEM manufacturer need from me?
A medical device OEM manufacturer typically needs: (1) design inputs — drawings with GD&T, material specs, and biocompatibility/sterilization requirements; (2) quality agreement defining QMS expectations (ISO 13485, FAI, change control); (3) quantity and lead time; (4) documentation requirements (MTRs, CoC, FAI, process validation). MakerStage works as a manufacturing partner to OEMs: we route work to ISO 13485 certified facilities when needed and provide the documentation packages required for your device history record and regulatory submissions.
Related Resources
Supplier qualification, change control, and cost analysis for medical device and regulated manufacturing.
Ready to Start Your Medical Device Project?
Get a quote for your medical device manufacturing needs with full regulatory compliance and expert engineering support.