MEDIcept Insights
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...
Threat Modeling for Medical Devices
You’ve just realized that your medical device has a connection to the outside world and meets the definition of a cyber device per FDA guidance “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.” As the initial shock wears...