The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
To ensure patient safety, medical device manufacturers are required by the Food and Drug Administration and other regulatory bodies to perform biocompatibility evaluations on their devices per standards, such as the AAMI-approved ISO 10993-1:2018 (ANSI/AAMI/ISO 10993-1:2018). However, some of these...
It is D-day, or the Day of Application (DoA) for the Medical Device Regulation (MDR) EU 2017/745. Years of hard work have preceded this date to prepare for this new regulation. The key message of the MDR is to minimize...
It is important to have an appropriate testing protocol in place for this relatively new medical technology. Medical devices have become increasingly complex over time and incorporation of “smart” features has become commonplace. These improvements may increase effectiveness of implantation,...
Our technical consulting group at Nelson Laboratories acts as a bridge between medical device companies and regulatory bodies, putting us in a good position to understand both sides and what they need from each other. This also creates an opportunity...
