If you're asking which FDA pathway fits your device, the short version is this: it comes down to how FDA views your device's risk, and whether a legal predicate already exists for it. A 510(k) works when you can show substantial equivalence to something already on the...
Regulatory expectations are evolving rapidly — driven by increased FDA scrutiny, modernization initiatives, and the growing role of data and artificial intelligence in regulatory review. MEDIcept’s Knowledge Hub brings together expert insights, white papers, and...
The FDA’s transition to the new Quality Management System Regulation (QMSR) introduces expanded risk-based expectations, deeper inspection focus, and additional FDA-specific requirements aligned with ISO 13485. Manufacturers should begin preparations now for the February 2026 compliance deadline.
Cybersecurity in medical devices has never been more critical. As connected technologies advance, so too do the risks posed by cyber threats—threats that could have direct consequences for patient safety. In a recent MD+DI article, MEDIcept’s own Gregg Van Citters,...
The European Commission (EC) introduced 2017/746, the In Vitro Diagnostic Regulation (IVDR) back in 2017, with a transition period of 5 years, entering into force on 26 May 2022 (with differences for certain articles). As the deadline loomed, it became apparent that...
As the medical device industry moves into 2025, manufacturers must stay ahead of the latest regulatory changes. The FDA and EU are implementing several significant updates that will impact various aspects of device development, approval, and post-market surveillance....
We are excited to announce the release of our latest case study showcasing how MEDIcept guided POLARISᴬᴿ through the complex regulatory landscape to achieve FDA 510(k) clearance for their groundbreaking STELLAR Knee augmented reality technology. By engaging MEDIcept’s...
We are thrilled to announce the successful 510(k) clearance of Sira Medical's innovative augmented reality (AR) preoperative surgical planning application! Our dedicated team at MEDIcept provided essential regulatory guidance, cybersecurity expertise, and usability...
Postmarket surveillance is a crucial aspect of medical device safety and cybersecurity risk management. It is the primary means of gathering information about how your device performs in the real world so you can make improvements that deliver better diagnoses or...
With a freshly completed threat model in hand, you turn to your next task: create the corresponding cybersecurity risk assessment. You identified some threat mitigations while constructing your threat model, perhaps making some design decisions intended to limit your...