Knowledge & Resources

❌The Myth: The Best Device Wins the Market! Many medical device manufacturers operate on a simple assumption: if the device works better than what is currently on the market, it will succeed. Build the best robot, win the market. This belief is understandable. It reflects how most competitive industries function. In MedTech, it is dangerously […]

AI Regulation meets MDR: High-Risk AI Requirements for Medical Devices This document is aimed at manufacturers who are adding an AI component to an existing MDR-compliant medical device, thereby bringing it within the scope of the High-Risk AI (HRKI) category under the AI Regulation. Purpose The AI Regulation document links the requirements of the EU

❌The Myth: MedTech Is Purely a Hardware Industry Ask most people to picture a medical device, and they will think of a scalpel, an implant, or a diagnostic machine. That image is understandable but increasingly incomplete. The idea that MedTech is defined by physical products belongs to another era of healthcare. Today, some of the most

❌ The myth: AI is transforming medical devices. Right now. On scale. Consequently, the conference keynotes say so. The investor decks confirm it. As a result – if you are not already deploying AI, you are falling behind.  The data tells a different story.  Still Mostly in the Pilot Phase  The global market for AI-enabled medical

❌ The myth: A great Product sells itslef, Regulatory Strategy can come later. Many MedTech manufacturers share the same assumption: the technology works, the clinical need is clear, and regulatory paperwork is just a final admin step. This belief has delayed, derailed, and ended market entry for otherwise strong products.  Regulatory strategy is not a

Wearable Devices and Health Apps ❌ The myth: If my wearable device or health app collects data through a smartphone, smartwatch, or fitness tracker, the entire system including the consumer hardware needs CE marking as a medical device ✅ The reality: The regulatory requirements depend entirely on the intended purpose of the software, not the

A great prototype means you’re ready for market ❌ The myth: Once we have a working prototype and positive user feedback, we can quickly move through CE marking and launch ✅ The reality: A functional prototype is merely the foundation – regulatory readiness requires complete traceability throughout your entire development process. The MDR demands that

Fault Tree Analysis (FTA) excels when you need: Top-down analysis requirements: Working backwards from a known hazardous situation or adverse event to identify all possible contributing causes. FTA excels at analysing how multiple component failures or conditions could combine to create a specific undesired event. Complex system interactions: For devices where multiple subsystems must fail

Continuing our series debunking common misconceptions in Regulatory Affairs. The myth: Many MedTech manufacturers treat gap analyses as administrative exercises. Documents created to satisfy auditors or tick a compliance box. They’re often seen as retrospective paperwork rather than proactive tools. The reality: A well-executed gap analysis is a strategic planning instrument, not documentation for its

This month, the FDA replaced its 2018 Pre-RFD guidance with significant updates that impact how manufacturers prepare and submit requests. High impact changes The vague “request a meeting” approach is gone. FDA now distinguishes between two structured meeting types: informational meetings (pre-submission, 6-week timeline) and explanatory meetings (post-assessment, 2-week timeline). Your SOPs will need updating.