Show Notes
Anyone looking to bring a medical device to the European market will inevitably face one central question: what exactly is a Notified Body – and why does it matter so much? QA expert Paul Griffin explains how the European conformity assessment system fundamentally differs from the FDA process, what to look for when choosing the right Notified Body, and which misconceptions regularly cost US companies time and money.
More from MedTech Unfiltered
Most of the MedTech companies today operate across borders – and inevitably run into cultural friction points along the way.
European MedTech startups with ambitions in the US, and US manufacturers looking to enter the european market, sooner or later run into the same problem: development and cost-efficient manufacturing rarely operate in the same time zones.
Ventricular fibrillation and ventricular tachycardia must be detected reliably and in real time. Software developer Halil Özer explains what it takes to train AI-based ECG algorithms, how AI-driven detection compares to traditional methods in noise handling, speed and shock decisions, and what AI Act, FDA and MDR require when it comes to documenting these systems.
Medical devices are not ordinary IT systems: if a bakery's server goes down, they simply sell fewer cookies for a few hours. If a defibrillator or insulin pump is compromised, patients' lives may be at stake. In this episode, system architect and cybersecurity expert Robert Feld explains why cybersecurity in networked medical devices is a discipline of its own, what "Secure by Design" looks like in practice, and how AI models are currently rewriting the rules.