European Notified Bodies are under intense scrutiny by Competent Authorities, and that oversight has filtered down to their clients. A few years ago, there were more than 80 Notified Bodies authorized to audit and certify medical devices. Today there are 57 and that number is expected to drop further in the next few years.
A set of standards published by UL to address medical device cybersecurity issues will soon be adopted by the US Food and Drug Administration to help manufacturers support security assurance claims. The UL 2900 standards were developed to provide manufacturers with testable and measurable criteria to assess medical device software vulnerabilitie
The US remains the largest medical device market in the world but gaining regulatory approval from the FDA is not fast, cheap or easy. In this one hour webinar, we demystify the process and explain what you need to do before starting your 510(k) submission, what the FDA wants to see, and how to avoid problems that delay or derail submissions.
Post-market surveillance (PMS) is complex and often misunderstood by device manufacturers. Europe's new Medical Devices Regulation (MDR) adds to the complexity of complying with specific PMS and post-market clinical follow-up (PMCF) requirements.