Hilde Viroux News Today : Breaking News, Live Updates & Top Stories | Vimarsana

The EU Regulation 745/2017 on medical devices (EU MDR) lists in Annex XVI several beauty devices that the EU Commission wants to regulate as medical...

The 6-Step Checklist For IVDR Compliance By Hilde Viroux and Hans Mische, PA Consulting The in vitro diagnostic devices industry has until May 25, 2022 to bring products, documentation, and quality management systems into compliance with the new EU Regulation on In Vitro Diagnostic Devices 746/2017 (IVDR). This regulation is a major revision, focusing on patient safety, requiring more clinical evidence, improving traceability in the supply chain, and enforcing a proactive post-market surveillance system to ensure early detection of problems. The past year presented a challenge in implementing...

3 Tips For Designing At-Home Monitoring Devices That Deliver Actionable Information By Anna (Ronning) Cohen and Hilde Viroux, PA Consulting We’re all seeing it in real time: Healthcare is increasingly shifting from clinical settings to our homes. The COVID-19 pandemic has accelerated the development of at-home monitoring products and many are collecting data in the background without requiring specific user action. This acceleration is not likely to slow down post-pandemic. In this article, we define “passive at-home monitoring tools” as non-invasive products that continuously monitor e...

The 3 Compliance Aspects For Passive Predictive Monitoring Device Success By Anna Ronning and Hilde Viroux, PA Consulting The healthcare and life science industry has been undergoing a digital transformation, and the global COVID-19 public health emergency has accelerated the development of at-home monitoring products. With this shift, at-home monitoring devices are focusing on a passive approach collecting data in the background. Understanding the regulatory compliance landscape is critical for getting these products on the market and in patients’ hands quickly. In this article, we define ...