The Regulatory Team here at Advena UK recently attended a 6 hours’ customised refresher course on Biological Safety and Biocompatibility Testing. We understand it is not always
Advena offers the service of designated Person Responsible for Regulatory Compliance (PRRC) on behalf of a Manufacturer but what is a PRRC, why is it needed and
The Regulatory Shift: From MDD/AIMDD ➡ MDR This shift has introduced more rigorous requirements for clinical evidence, impacting all devices previously CE marked under MDD or AIMDD.
Why claim equivalence? In the complex landscape of EU MDR, the concept of equivalence is a powerful tool for manufacturers. Demonstrating equivalence can significantly streamline the clinical
