Certifications

Innovatek Medical Inc. has been certified to the new ISO 13485:2016 Medical Device Single Audit Program (MDSAP).

Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. ISO 13485:2016 replaces the old ISO 13485:2003. All medical device manufacturers must obtain the new certificate by March 1, 2019. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations with Medical Device Single Audit Program (MDSAP) recognized registrars.

What is ISO 13485:2016?

ISO 13485 is the international standard that defines quality management system requirements for organizations involved in one or more stages of the medical device product life cycle. This includes design and development, production, storage and distribution, installation or servicing of a medical device. ISO 13485:2016 can also be used by suppliers or external parties that provide product and quality management system-related services.

This standard helps to ensure the consistent application of quality requirements in the medical devices and in-vitro diagnostic devices industry. It is being applied as part of the regulatory regime for medical devices in a number of countries.

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) audit process was designed to provide a single audit that covers regulatory requirements of medical devices – quality management systems and regulatory purposes (ISO 13485), as well as the specific requirements of medical device regulatory authorities participating in the MDSAP (Australia, Brazil, Canada, Japan, and the US Quality System Regulation).

Innovatek - Model C-Chip - Disposable Optical Plastic Haemocytometer

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