Unique cross-linking process of hyaluronic acid can effectively control the residue of cross-linker in compliance with regulations of each country and requirments for clinical application.
Aseptic manufacturing meets ISO 14644 and ISO 13408
Aseptic manufacturing meets ISO 14644 and ISO 13408 standard requirement.
Moist Heat Sterilization Equipment Meets ISO 17665
The process of moist heat sterilization for syringe utilizes international reputed brand sterilizer in compliance wih ISO 17665
Unique Cross-Linking Process of Hyaluronic Acid
Unique cross-linking process of hyaluronic acid can effectively control the residue of cross-linker in compliance with regulations
of each country and requirments for clinical application.
Contract Product Development and Manufacturing
Tissue Regeneration Medical Device Development
MBI offer our partner with expertise in the following application areas:
✓ Collagen-Based Biomaterials for Applications in Soft/Hard Tissue Repair & Regeneration.
✓ Cross-Linking Technologies of Hyaluronic Acid for Applications in Dermal Filler and Osteoarthritis (OA) Treatment.
✓ Hyaluronic Acid Medical Device for Applications in Ophthalmic Viscosurgical Devices (OVD).
✓ Synthetic Calcium Phosphate Biomaterials & Bone Cement for Applications in Bone Regeneration.
OEM/ODM Service with Regulation-Compliant Products
Medical device development and contract manufacturing at our GMP/ISO13485 production facility use the same quality management system (QMS) to speed up development processes and provide reliable services at reasonable cost.
We have both manufacturing and research facilities and our OEM/ODM service include:
✓ Design Controls
✓ Process Development
✓ Manufacturing Process Validation
✓ Packaging Design and Validation
✓ Sterilization Validation
✓ Product Stability Testing
✓ Safety and Efficacy Testing
✓ Quality Control Testing
✓ Design/Process Transfer
✓ Regulatory Compliance
If you are interested in a contract or co-development partnership, please contact us.