Noticias y novedades

Are you a developer or manufacturer of Artificial Intelligence (AI)-based medical devices? Then you should know about the latest opportunity offered by MHRA, the UK’s regulatory agency. They have opened applications for the AI Airlock regulatory sandbox, created to tackle [...]

The IVDR (In Vitro Diagnostic Regulation 2017/746) has drastically changed the regulatory landscape in Europe for IVD devices. The new regulations not only impose stricter risk classifications but also demand rigorous clinical evaluation and post-market surveillance. What should you know [...]

In the current context, Switzerland offers unparalleled opportunities to expand your business in the healthcare sector. Here’s why now is the perfect time: 🔹 Stability and Trust: Switzerland is known for its political and economic stability, making it an [...]

If your medical device is not yet fully compliant with the Medical Devices Regulation (MDR), retaining "legacy device" status is crucial to continue placing your products on the EU market. Article 120 of the MDR outlines key deadlines that [...]

Compliance with the Medical Devices Regulation (MDR 2017/745) is crucial for marketing medical devices in Europe. Our MDR consulting services ensure your products meet all regulatory requirements, facilitating their entry and maintenance in the European market. 🔍 Complete Technical [...]

📅 From September 25th to 28th, 2024, we will be in Düsseldorf, Germany, ready to share the latest news about our services and discuss how we can support you in the rehabilitation and care sector. 👥 Our expert colleagues, [...]

If you're a manufacturer, importer, or authorized representative in the medical device industry, registering in EUDAMED is key to ensuring compliance with EU regulations. Not sure where to start? Let’s break it down for you! 📝 Step 1: Actor [...]