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
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows.
The new European Union (EU) Medical Device Regulation (MDR) will impact medical device manufacturers’ product-development timelines. All companies intending to sell their devices in Europe must understand the new MDR and how it differs from the previous directives, especially in...
Colorants are often added to the substrates and material components of medical devices with the primary intent of improving the usability of the devices. For instance, color coding can assist users in matching devices or sizes together when multiple options...
Sterilizing medical devices via ethylene oxide gas is an effective and common practice within the industry. EO gas is active at a relatively low temperature compared to other methods, such as steam, and it is compatible with plastics, polymers, and...
Medical devices marketed in the European Union are required to comply with a set of medical device directives called the “medical devices regulation” or MDR for their Conformité Européenne (CE) marking and marketing in Europe. Over the past decades, the...
Medical plastics permeate the medical device industry with a remarkable diversity of application. They seem to be everywhere in healthcare: from protective barriers and low-risk device components (eg. instrument housings and handles) to devices of the highest potential risk (eg....
