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
“The MDR requires manufacturers to submit significantly more documentation covering the total product lifecycle than previously under the MDD. A critical change with MDR is the clinical evidence necessary to demonstrate the safety and efficacy of the device… Manufacturers must...
“The [European Union’s] MDR aims to provide a higher level of protection for patients, but the transition has been anything but smooth. Manufacturers are struggling to keep up with the extra checks, and the EU notified bodies are overwhelmed,” writes...
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...
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...
Learn from the industry-leading experts at Nelson Laboratories in the three-day webinar series Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes including FDA, ISO, USP, and MDRs. The experts at Nelson Labs are teaming with MD+DI to...
