A Risk-Based Approach for Biocompatibility

The updated standard highlights that particular attention will be focused on the device materials used, rationale for biocompatibility tests performed, the compatibility of these materials with biological tissues, and the impact of the manufacturing processes on the material properties.

EU MDR Compliance

Gearing Up for EU MDR How cleanroom bioburden information can support biocompatibility assessments In medical device manufacturing, low bioburden levels are essential. We address EU MDR compliance from a bioburden and biocompatibility perspective for sterile medical...