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...
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...
Medical device manufacturers must increasingly devote resources to identifying and managing cybersecurity risks and features of their devices. Devices that once might have been considered to have no network connectivity have been brought into regulatory focus as...
Introduction Establishing a robust compliance program is essential for any organization, particularly within the healthcare sector, where adherence to federal laws and regulations is critical. The Office of Inspector General (OIG) of the Department of Health and...
Introduction Secure design best practices (and various standards and guidance) recommend penetration testing (pentesting) be included in the secure development life cycle and conducted by a team independent of the product developers and testers. Testing should begin...
The U.S. Environmental Protection Agency (EPA) has issued a final rule aimed at limiting emissions of ethylene oxide (EtO), a carcinogenic chemical extensively used in the sterilization of medical devices, with a focus on enhancing medical device regulation. This new...