MEDIcept Insights
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...
Cybersecurity Post-Market Surveillance
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...
Cybersecurity Risk Control
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...