Medegen’s Manufacturing Services group is dedicated to providing disposables contract manufacturing to the Medical Device Industry. With FDA registered and ISO 13485 certified operations in Ontario, CA and Tijuana, Mexico,  we offer a broad range of capabilities and solutions to your device production requirements.

Medegen’s comprehensive experience, extensive capabilities and exclusive focus on medical disposables manufacturing offers our clients a valuable extension of their capabilities and capacities.

Our Ontario, CA based Program Management provides our customers with a convenient and effective “front end” to a wide array of manufacturing capabilities and services. Complete management from product development through manufacturing and sterilization to distribution is available.  Coupling Medegen’s Ontario custom mold making and cleanroom molding with our Tijuana assembly facilities enables us to offer optimized capabilities, efficiencies and economies.

Carefully designed system flexibility allows Medegen to tailor its offerings to the specific needs of any given customer. Customization of services yields an efficient and effective complement to our clients and results in sincere partnering. Our capabilities include:

Program Management
Contract management
Comprehensive project modeling
Financial analysis
Regulatory compliance
Quality management
Technical sourcing
Risk analysis

Product/Process Design and Development
Manufacturability analysis
Plastic part design
Material selection
Prototyping
Mold design/fabrication
Process design/DOE/FMEA
Process validation (IQ OQ, PQ)
Equipment sourcing
Tool/fixture design
Test procedure development
Sterile package design
Sterilization validation
Product characterization (aging, transit, biocompatibility)

Supply Chain Management
Vendor sourcing/establishment
Contract management
Material procurement
Tier 1 ERP system
Logistics
Warehousing
Global distribution

Product Manufacturing
M8 Cleanroom molding
Component secondary operations
M8 and M6 assembly cleanrooms
High volume, automated assembly/testing
Low and medium volume manual assembly
Solvent/adhesive/UV bonding
Pad printing/hot stamping
Ultrasonic welding
Swaging/staking/skiving
Sterile barrier packaging
Inspection systems (CMM, video, leak, flow, pull, burst)
Final packaging
Sterilization management (EO, Ebeam, gamma)

Regulatory Compliance
ISO 13485/FDA QSR
CE Marking
Compliant, efficient quality system
Submission assistance/management
Comprehensive documentation (DHF, DMR, DHR)