Certifications

Our quality system assures compliance while providing the flexibility to meet the unique customer and regulatory requirements of each of our client's projects. The Gener8 Quality Management System has been certified by BSI to the following standards and is designed to comply with the FDA Quality System Regulation (21 CFR 820) and the Canadian Medical Device Regulation.


ISO 9001:2008 | The provision of turnkey, development, and manufacturing solutions for instruments, subsystems, OEM components and circuit boards for various industries. (BSI Certificate: FM 600355)

ISO 13485:2003 The provision of turnkey, development, and manufacturing solutions for instruments, subsystems, OEM components and circuit boards (BSI Certificate: MD 600989)

EN ISO13485:2012 The provision of turnkey, development, and manufacturing solutions for instruments, subsystems, OEM components and circuit boards (BSI Certificate: MD 600989)


Our quality system was developed to completely support product development, production and post-production activities. However we have the flexibility to work with a customer’s in-house system, if that is desired.