Effective quality management systems are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world. ISO 13485 provides a focus for the quality management system requirements for medical device manufacturers.
Free trade of medical devices within the European Union is achieved through compliance with the requirements of the applicable EU Instructions:
- Active Implantable Medical Devices Instruction (AIMI)
- Medical Devices Instruction (MDI)
- In Vitro Diagnostic Instruction (IVI)
Independent, third party assessment of a quality management system to ISO 13485 assists in meeting the compliance requirements of the EU Instructions.
Since January 2003, Canada has required that medical device manufacturers marketing products in Canada must have a quality system certified to ISO 13485 under the CMDCAS program.
In addition to quality systems approvals, BSI can also offer a fast track to FDA approval under FDA 510K Review program.