Why IVD Developers Must Embrace the IVDR Transition Now
This blog delves into the crucial transition from the In Vitro Diagnostic Device Directive (IVDD) to the IVDR, highlighting the pressing need for developers to take immediate action.
Month: November 2023
WOUNDS UK: Models and Methods to Support the Development of Novel Burn Wound Antimicrobial Treatments
WOUNDS UK Journal Article Vol: 19 | Issue: 04; November 2023 By Jennie Ritchie (NAMSA Global Associate Product Marketing Manager – QCSA Laboratory Services), Samantha Westgate (Former NAMSA Scientific Director, Microbiology and In Vitro Development) and Jim Pomonis (Former NAMSA Associate Vice President, Scientific Affairs) Despite the advances in burn wound management, infection is a … Continued
What is an EDC System and How Does it Support Clinical Trials?
On June 2, 2023, the U.S. Food and Drug Administration (FDA) updated and posted the Final Guidance for Industry and Food and Drug Administration Staff: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.
MDCG 2023-4: Medical Device Software (MDSW) – Hardware Combinations
In this blog, we assess if MDCG 2023-4, published in October 2023, lessens the regulatory burden and clarifies the route to conformity for medical device Apps.