Storage & Handling Condition: Key aspects and their significance The ever-evolving medical device industry is subject to comprehensive guidelines designed to ensure the safety and efficacy of healthcare products. With…
The European Database for Medical Devices (EUDAMED) plays a crucial role in the regulation and surveillance of medical devices within the European Union. With the introduction of the regulations (Art.…
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…
Critical warnings: Essential aspects and their significance The evolving world of medical devices is subject to complex regulations designed to ensure the safety and effectiveness of healthcare products. With the…
SWISSDAMED - The swiss UDI database The Mutual Recognition Agreement (MRA), one of the main agreements between the EU and Switzerland facilitating bilateral trade in a number of key sectors…
Streamlining Compliance: OPAL Labelmanagement & Europe IT Consulting => Perfect Pair for UDI and Labeling As medical device manufacturers prepare to comply with the EU Medical Device Regulation (MDR), one…
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…
Marked by strong economic development, Asian countries are gradually implementing UDI and regularizing their regulatory environment for medical devices. It is therefore smart to know where these countries are in…
Which details of the critical warnings have to be provided to EUDAMED, to the GUDID ? The Label information, the instructions for use, or both ? What about the contra…
New differing requirements now apply to EU and Swiss medical device manufacturers.As already mentioned in a previous article (MRA between Switzerland and EU no longer valid), Switzerland is considered as…