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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)