Medical Device Injection Molding
FDA compliant medical device manufacturing with biocompatible materials, clean room protocols, and ISO 13485 certification. Specialized in surgical instruments and critical medical components.
Medical Device Manufacturing Capabilities
Comprehensive medical device injection molding across all FDA device classes with specialized expertise in critical healthcare applications.
- Surgical handles
- Instrument housings
- Disposable tools
- Laparoscopic components
- Endoscopic parts
USP Class VI, ISO 10993 biocompatibility
- Test strip housings
- Sample containers
- Optical components
- Analyzer parts
- Cartridge assemblies
Optical clarity, chemical resistance
- Syringe components
- Inhaler parts
- Pump housings
- Valve assemblies
- Needle hubs
Sterile manufacturing, particle control
- Catheter components
- Pacemaker housings
- Orthopedic implants
- Dental components
- Prosthetic parts
Long-term biocompatibility, ISO 10993
- Pipette tips
- Microplates
- Tube caps
- Reaction vessels
- Filter housings
Chemical inertness, low extractables
- Sensor housings
- Electrode components
- Monitor casings
- Cable assemblies
- Interface components
Electrical safety, skin contact safe
Biocompatible Materials Portfolio
Extensive selection of FDA-approved and biocompatible materials meeting USP Class VI and ISO 10993 standards for medical device applications.
Excellent chemical resistance, high temperature stability, radiopaque options
Spinal implants, surgical instruments, catheter components
USP Class VI, ISO 10993
Steam, EtO, Gamma, E-beam
Transparent, chemical resistant, repeated sterilization capability
Surgical instruments, connectors, housings
USP Class VI, ISO 10993
Steam, EtO, Gamma
Optical clarity, impact resistance, gamma stable
Dialysis components, blood oxygenators, housings
USP Class VI, ISO 10993
EtO, Gamma, E-beam
Clean Room Manufacturing Environment
ISO 8 clean room facilities with controlled environment manufacturing for critical medical device components.
ISO 8 Clean Room
Controlled particulate environment with less than 3,520,000 particles ≥0.5μm per cubic meter
- HEPA filtered air supply
- Positive pressure maintenance
- Temperature and humidity control
- Personnel access control
Environmental Monitoring
Continuous monitoring of critical environmental parameters
- Particle counting systems
- Temperature/humidity logging
- Differential pressure monitoring
- Microbial sampling
Personnel Protocols
Strict personnel training and gowning procedures
- Clean room training certification
- Gowning and degowning procedures
- Personal hygiene protocols
- Access restriction systems
Equipment Qualification
Validated and calibrated manufacturing equipment
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
- Preventive maintenance programs
- Batch records and manufacturing logs
- Environmental monitoring data
- Equipment calibration certificates
- Personnel training records
- Material certificates of analysis
- Process validation documentation
- Change control procedures
- Deviation investigation reports
Regulatory Compliance & Quality Systems
Comprehensive quality management systems ensuring compliance with FDA, ISO, and international medical device regulations.
Design, development, production, and servicing of medical devices
- Regulatory compliance
- Risk management
- Process control
- Continuous improvement
Class I, II, and III medical device manufacturing
- FDA compliance
- 510(k) support
- QSR adherence
- Audit readiness
Design planning, input, output, review, verification, validation
- Design history file
- Risk analysis
- Verification testing
- Design transfer
Risk analysis, evaluation, control, and post-production monitoring
- Hazard identification
- Risk assessment
- Control measures
- Residual risk evaluation
Cytotoxicity, sensitization, irritation, systemic toxicity testing
- Material selection
- Safety validation
- Regulatory submission
- Risk mitigation
Installation, operational, and performance qualification
- Process understanding
- Control strategy
- Continuous monitoring
- Lifecycle approach
Medical Device Testing & Validation
Comprehensive testing protocols ensuring medical devices meet safety, efficacy, and regulatory requirements.
Cell viability assessment using extract and direct contact methods
Skin sensitization potential evaluation using guinea pig or mouse models
Skin and eye irritation assessment for external contact devices
Acute and subacute systemic toxicity evaluation
Blood compatibility testing for blood-contacting devices
Local tissue response evaluation for implantable devices
Medical Device Success Stories
Real-world examples of successful medical device manufacturing projects with regulatory compliance and quality excellence.
Precision surgical instrument housing requiring biocompatibility, sterilization compatibility, and ergonomic design for repeated use in operating rooms.
Repeated steam sterilization with dimensional stability
PPSU material with precision molding
ISO 13485, FDA 510(k), USP Class VI
1000+ sterilization cycles, zero failures
Critical component for long-term implantable device requiring extensive biocompatibility testing and long-term stability validation.
Long-term biocompatibility and stability
Medical grade PEEK with clean room molding
Full ISO 10993 battery, 26-week implantation
FDA approval, successful market launch
Partner with Medical Device Manufacturing Experts
Get FDA compliant manufacturing for your medical devices. Our ISO 13485 certified facility ensures regulatory compliance and superior quality for critical healthcare applications.