Regulatory and Compliance
Adept Medical Limited uses a purpose built facility to clean, assemble and package the NeoZoline range of ENT products and accessories. This facility is also available to manufacture products though Adept Medical Limited on an OEM basis.
The production facility includes an ISO Class 7 (Grade C, Class 350) cleanroom which meets the most stringent world class standards for the production of implantable medical devices.
All sterile products are packaged within an ISO Class 5 (Class 3.5) Lamina Flow Cabinet or Class II Biological Safety Cabinet, and are terminally sterilised by Ethylene Oxide.
Regulatory Compliance
The Quality System of Adept Medical Limited complies with the requirements of the Medical Device Directive 93/42 EEC, ISO13485:2003 and CMDCAS ISO13485:2003. Adept Medical is externally audited by SGS UK.
We also meet the requirements of U.S. FDA Good Manufacturing Practices (GMP) and Quality System Requirements (QSR) of CFR Title 21 part 820.
Adept Medical Limited is registered as a Medical Device Manufacturer with the FDA (Registration #3006098219) and with Health Canada (Company ID # 124848).
CE – MDD ISO13485:2003, Certificate # CA05/3421
93/42 EEC, Certificate # GB04/63721
CMDCAS ISO13485:2003, Certificate # GB04/63722
The production facility includes an ISO Class 7 (Grade C, Class 350) cleanroom which meets the most stringent world class standards for the production of implantable medical devices.
All sterile products are packaged within an ISO Class 5 (Class 3.5) Lamina Flow Cabinet or Class II Biological Safety Cabinet, and are terminally sterilised by Ethylene Oxide.
Regulatory Compliance
The Quality System of Adept Medical Limited complies with the requirements of the Medical Device Directive 93/42 EEC, ISO13485:2003 and CMDCAS ISO13485:2003. Adept Medical is externally audited by SGS UK.
We also meet the requirements of U.S. FDA Good Manufacturing Practices (GMP) and Quality System Requirements (QSR) of CFR Title 21 part 820.
Adept Medical Limited is registered as a Medical Device Manufacturer with the FDA (Registration #3006098219) and with Health Canada (Company ID # 124848).
CE – MDD ISO13485:2003, Certificate # CA05/3421
93/42 EEC, Certificate # GB04/63721
CMDCAS ISO13485:2003, Certificate # GB04/63722