The European Union has undertaken several measures to address the difficulty of implementing the Medical Device Regulation (MDR), but these grace periods are coming to an end. The EU’s Medical Device Coordination Group (MDCG) recently advised medical device manufacturers that time is running out to reapply for a CE mark for existing devices in a position paper that serves as a warning that stragglers may be left out in the transition.
The FDA has reissued draft guidance for premarket cybersecurity considerations four years after the previous draft guidance, and eight years after the issuance of the most recent final guidance. While this draft guidance is not the final word on this policy, we would advise our clients that it represents a fundamental shift in the agency’s approach to cybersecurity, one that comes with a substantially more demanding set of requirements in the premarket phase of device development.
The FDA’s approach to validation of computer systems used in device manufacturing IT systems hasn’t drawn the attention that software as a medical device has, but that doesn’t mean this requirement hasn't wanted for controversy.
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
