Second Opinion®- User Manual

Know what you're looking for? Search the User Manual.

Regulatory Compliance

SecondOpinion® complies with the regulatory requirements of the following:


●    ENISO 13485:2016 entitled Medical Devices.

●    Quality Management Systems Requirements for regulatory purposes, FDA 21 CFR Part 820 entitled Quality System Regulation (QSR).

●    EUMedical Device Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Device (MDR)

●    MedicalDevice Single Audit Program (MDSAP)

●    Canadian Medical Devices Regulations SOR 98-282

●    The Health Insurance Portability and Accountability Act (HIPAA)