MEDIcept Insights
QMSR Compliance Deadline: February 2, 2026
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.
Strengthening Medical Device Security in the Age of AI Threats
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,...
High-Risk IVDs Drive Immediate Transition to IVDR
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...
Top 5 Upcoming FDA and EU Regulations – What to Know for 2025
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....
Unlocking Success in Regulatory Compliance: POLARISᴬᴿ's Journey to FDA 510(k) Clearance with MEDIcept Consulting Experts
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...
Navigating FDA Clearance: Sira Medical's Success Story with MEDIcept
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...