ISO 14971 Risk Management Process
The ISO 14971 Risk Management standard defines principles for a risk management process of medical devices. The requirements given in this standard help manufacturers to comply with the main regulations. So, by implementing an ISO 14971 Risk Management Process you can have a big step in your EU MDR, IVDR or FDA certification route. The… Read more
MDSAP – MEDICAL DEVICE SINGLE AUDIT PROGRAM
The Medical Device Single Audit Program (MDSAP) is led by Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer’s quality management system that will satisfy the requirements of the medical device regulatory authorities participating in… Read more