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
Validating cleaning instructions for a tray of reusable orthopedic devices is an important milestone on the path to obtaining FDA clearance for those devices. Although the process of validation can seem daunting at first, medical device manufacturers seeking to successfully...
Last week, Alpa Patel, Senior Scientist at Nelson Laboratories, and Kaumudi Kulkarni, Manager of Research and Development at Healthmark Industries, hosted the live webinar Endoscope Microbial Surveillance Testing Made Easy. The webinar was attended live by infection prevention professionals, sterile...
Consideration of human factors when designing a medical device should be a high priority. It is important that concerns regarding human factors are considered during the development phase of new medical devices. For many years, this phase of the process...
The following is a preview of the article Cleaning, Disinfection, and Sterilization Validations for Tissue Processing Equipment, featured in the February 2015 issue of MD&DI magazine, by Nelson Laboratories Senior Scientist Alpa Patel. ...
One of the most difficult questions for medical device manufacturers is which test soil to use for validating their reusable medical device’s cleaning instructions. The AAMI, ISO, and ASTM standards committees, as well as the FDA, have all been working...
