Mentor Media’s inception of the cleanroom endorsed it desire in its expansion into the healthcare supply chain. EN ISO 13485:2016 audit certified, Mentor Media can perform certain level of contract manufacturing in the healthcare products preassembly. i.e cleanroom cleaning, assembly, and sterile / non-sterile packaging of medical devices.
Mentor Media Cleanroom capabilities:
- NEBB certified ISO Class 7 and Class 8 cleanrooms, under operation occupancy state.
- Cleanroom operation’s microbiological limits level at PIC / S GMP Grade.
- Validated ISO 11607-1 sterile barrier packaging system.
Mentor Media customed solutions includes:
- Cleaning
- Assembly
- Primary Packaging
- Secondary Packaging
- Final Inspection
- Sterilization
Extending to our supply chain’s temperature-controlled warehousing, 3PL solutions and last mile operations expertise for global distribution.
All validations will be done inhouse or in cooperation with competent and accredited partners.
Mentor Media packaging serves a wide range of medical devices:
Consumables
- Devices such as syringes, sutures, staples, tubes, and stents
Orthopedics
- Braces used to correct existing problems or to provide stability in the skeleton and muscle system.
Cranium
- Skull fragments or its related accessory tools used for cranial fixation procedures.
Dental
- Steel wires and bracket, braces and screw like posts used in tooth canals or replace damaged or missing teeth.
Spinal Replacement
- Braces, screws, and brackets used to align bones down the center of the back. Corrective aids used to provide support for the body and protects the spinal cord.