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…
Europe IT Consulting receives successful ISO 9001 recertification without any "minor non-conformity" We are pleased to announce that Europe IT Consulting GmbH was successfully recertified by QS Zurich on July…
Important Update on EU Medical Device Regulation (EU MDR) Great news for medical device manufacturers! The EU MDR extension period offers some additional time for placing certain devices on the…