The U.S. Food and Drug Administration (FDA) has taken a proactive step to ensure the accuracy and compliance of medical device information by notifying medical device manufacturers of potential discrepancies…
Understanding Eudamed, UDI, and MDR: A Guide for Medical Device Manufacturers In the medical device industry, compliance with regulatory requirements is crucial for ensuring patient safety and product quality. One…
Which responsibilities you have as manufacturer according to MDRGeneral manufacturer obligations are defined in Article 10. Basically, you as a manufacturer must ensure that the products you place on the…
GUDID / EUDAMEDWhat already is true for food today is also becoming reality for medical products. Traceability must be ensured, with the overriding goal of optimizing patient safety. Preparations at…
We would like to inform you today about the latest developments regarding the Vigilance module in the EUDAMED database. This crucial module, scheduled to go live in 2026, will be…
Time is running out for the medical device industry to comply with the requirements of the Medical Device Regulation (MDR). To properly implement such complex regulations, it's essential to have…
Opportunities, Challenges, and Regulations India is one of the fastest-growing markets for medical devices globally. With an annual growth rate of approximately 16-17%, it presents significant opportunities for both domestic…
Bern, Switzerland - August 6, 2024 Swissmedic has announced the successful go-live of the Swissdamed Actors Module today. This marks a significant milestone in the regulatory framework for medical devices…
Basel, Switzerland – We at Europe IT Consulting GmbH are thrilled to announce a significant milestone in our ongoing efforts to support medical device manufacturers with compliance and regulatory requirements. (more…)
Medical Device Market in China: Current Developments and Interesting Details The Chinese market for medical devices is experiencing dynamic growth and offers numerous opportunities for companies worldwide. Here are some…