Noticias y novedades
Importers or Distributors: Who is Responsible for Medical Device Compliance?
Understanding the responsibilities of importers and distributors is fundamental to ensuring that medical devices comply with regulations and safely reach markets. Here’s a clear breakdown: Importer vs. Distributor: What’s the Regulatory Difference? Importer: This is the person or company [...]
Discover the 6 Steps to Successfully Obtain CE Certification
If you’re developing a medical or in vitro diagnostic device, obtaining the CE mark is essential to enter the European market. Here are the key steps: Classification: Determine the classification of your device (I, IIa, IIb, III for medical [...]
Exciting Update: Istituto Superiore di Sanità Now Accredited for IVDR!
A new key player has been designated for the In Vitro Diagnostic Regulation (IVDR)! The Istituto Superiore di Sanità (NB 0373), based in Italy, has been recently accredited as a notified body. With this addition, the total number of [...]
Innovation and Regulation: How the AI Airlock Sandbox Can Help Medical Device Manufacturers!
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 [...]
Global IVD Device Registration: IVDR – 2017/746 Challenges
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 [...]
Why is now the perfect time to introduce your Medical Devices in Switzerland?
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 [...]
🚀 See You at MEDICA 2024! 🚀
We’re excited to announce our participation in MEDICA 2024 in Düsseldorf, from November 11 to 14, at our stand Hall 6 / G62. 🌍✨ Why should you visit us? Because we’re ready to offer you the most innovative solutions [...]
🚨 Countdown for MDR Certification: Imminent Deadline for Legacy Devices!
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 [...]
🌟 Why Our MDR Consulting Services Are Essential in the Rehabilitation and Care Sector 🌟
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 [...]
