Noticias y novedades
🚨 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 [...]
🌟 We are excited to announce our participation in «Rehacare», The International Trade Fair for Rehabilitation and Care! 🌟
📅 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, [...]
🚀 Need to Register in EUDAMED? Here’s How to Get Started! 🚀
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 [...]
🌍 Looking to expand your business globally with medical devices or IVD products? 🚀 Here’s what you need to know about the Free Sale Certificate (FSC)
A Free Sale Certificate (FSC) is a crucial document for manufacturers aiming to export medical devices and in vitro diagnostic (IVD) products to international markets. This certificate confirms that the products are marketed in Europe, comply with European regulations, [...]
Regulatory Alignment Between the EU and Switzerland in In Vitro Diagnostic Medical Devices
On August 14, 2024, Swissmedic, Switzerland's regulatory authority for therapeutic products, announced its decision to implement the recent amendment to the European Union's In Vitro Diagnostic Medical Devices Regulation (IVDR). This move aims to ensure the stability of in [...]
August 6th, Swissmedic is rolling out key changes for registration and modification in the CHRN
🔗 New Process: All registration applications and modifications must now be submitted exclusively through the Swissdamed platform as of 6th Agust 2024. This marks a major step forward in the digitalization and regulation of the sector in Switzerland. 🕒 [...]
CMC MEDICAL DEVICES & DRUGS, S.L. Obtains ISO 13485:2016/A11:2021 Certification, Reaffirming Its Commitment to Quality and Safety in the Medical Industry
CMC MEDICAL DEVICES & DRUGS, S.L., a company dedicated to regulatory affairs and representation of medical devices, is pleased to announce that it has obtained the ISO 13485:2016/A11:2021 certification, an internationally recognized standard that defines the requirements for providing [...]
New Artificial Intelligence Law Comes Into Force Today, August 1, 2024: Key Points and Focus on High-Risk Devices
The European Parliament and the Council of the European Union have approved Regulation (EU) 2024/1689, establishing a uniform legal framework for the development, commercialization, and use of artificial intelligence (AI) systems across the European Union. The primary aim of [...]
