Insights

The FDA isn’t experimenting with AI anymore — it’s operationalizing it. | Medicept

Shawn Weed — Wed, 17 Dec 2025 14:45:00 GMT

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 practical guidance to help MedTech and Digital Health teams navigate complex regulatory, quality, and clinical challenges with confidence. Our resources are designed to support informed decision-making, reduce compliance risk, and enable right-first-time execution across every stage of the product development lifecycle.

Strengthening Medical Device Security in the Age of AI Threats | Medicept

Shawn Weed — Tue, 12 Aug 2025 13:00:00 GMT

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.

High-Risk IVDs Drive Immediate Transition to IVDR | Medicept

cthomas — Tue, 11 Mar 2025 15:00:00 GMT

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 the European Union (EU) risked a shortage of in vitro diagnostic medical devices (IVDs) because many companies were not ready to transition from the In Vitro Diagnostic Directive (98/79/EC) and Notified Bodies (NBs) were scarce and under-resourced for the sheer volume of applications necessary for market continuity.

Top 5 Upcoming FDA and EU Regulations – What to Know for 2025 | Medicept

cthomas — Mon, 13 Jan 2025 15:15:00 GMT

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. These changes are designed to improve patient safety, ensure the effectiveness of devices, and align U.S. standards with international regulations. For medical device manufacturers, staying on top of these regulatory shifts is critical to avoid delays, costly fines, and disruptions in market access. Here's a rundown of the top five FDA and EU regulations that you need to know, as they will shape the landscape for medical devices in the coming years.

Regulatory Compliance: POLARIS's FDA Clearance with MEDIcept Consulting

cthomas — Fri, 22 Nov 2024 15:00:00 GMT

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 regulatory experts early in the process, we helped streamline their submission and respond efficiently to FDA feedback, significantly reducing time to market. This collaboration not only ensured compliance but also empowered the POLARISᴬᴿ team with essential skills for future success.

Navigating FDA Clearance: Sira Medical's Success Story with Medicept

Medicept — Mon, 18 Nov 2024 15:30:00 GMT

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 testing support, ensuring a seamless submission process. This collaboration not only empowered Sira Medical with a clearer understanding of FDA requirements but also positioned them for future growth and funding.

Cybersecurity Post-Market Surveillance | Medicept

cthomas — Mon, 28 Oct 2024 13:30:00 GMT

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 therapies. The customer feedback process is a key entry point for field performance information into the quality management system.

Cybersecurity Risk Control | Medicept

cthomas — Thu, 24 Oct 2024 12:30:00 GMT

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 attack surface and embed security by design. Now it is time to apply further rigor to elucidate the risks associated with your identified threats and determine how to control those risks.

Threat Modeling for Medical Devices | Medicept

cthomas — Mon, 21 Oct 2024 13:30:00 GMT

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 off, you realize you have no idea how to go threat modeling and think, “Can’t I just do an FMEA?”

Securing Your Medical Device Software Development Life Cycle | Medicept

cthomas — Tue, 15 Oct 2024 14:30:00 GMT

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 cyber devices with FDA’s most recent guidance on cybersecurity, “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.” Because cybersecurity must be designed into the product to be effective, security is a core requirement of the product.