Regulatory Support

Medical Device Quality and Certification

We assist clients with laboratory testing, certifications, compliance and regulatory affairs to the extent required by each project. These may include:

  • FDA requirements (510k notification, etc)
  • GMP/cGMPs (Good Manufacturing Practices)
  • Quality Management Systems (QMS), QSRs
  • CE Mark, ISO Certification (9000, 9001, 9002, 13485…)
  • EMC, EMI, IEC 60601 Compliance
  • CSA/UL registration
  • IEC 60601 and various FDA Cert’s and registration requirements

FDA Specialists

“Guardion Health Sciences was extremely fortunate to have discovered DeviceLab. We were challenged in finding a team that could correctly interpret the Hetrochromatic Flicker Photometery technology utilized by Professor Richard Bone in his invention of the MapcatSF. The entire team at DeviceLab quickly understood our objective, and were proactive in making suggestions to Professor Bone on how to make the MapcatSF the best in show.
Mission accomplished, the MapcatSF is now acclaimed the best device available for measuring the Macular Pigment Optical Density. Thank you to Dac Vu, Le Bui and the entire DeviceLab team.”

DeviceLab is an industry leader in the design of innovative and complex projects. We’ve worked together often and I could not find a more exceptional company to work with.

– Richard W. Henson

DeviceLab is a industry leading company who not only knows management and techniques, but also applies them to create extra value in every project they undertake.

– Thomas Witty

I have worked with DeviceLab on several development projects, alternatively as a client and a technical consultant. As a service provider, DeviceLab was exceptionally resourceful, always ready to have creative solutions for any problem that we encountered

– Brigitte Phan