Quality & Regulatory Compliance Issues in the Medical Device & Diagnostics Industry

Medical device companies have been scrambling over the past few years to ensure compliance with EU MDR by the mandatory deadline of May 26, 2020....

In December 2019, the European Parliament approved the second corrigendum of EU MDR. Typically, a corrigendum is comprised of minor corrections to...

The new European Union Medical Device Regulation ("EU MDR") represents one of the most significant and impactful regulations within the medical...

One of the most prominent regulations within the medical device industry is ISO 13485, which specifies requirements for a quality management system...

Since the 1990’s, there had been very few updates to European regulations in the medical device industry. That all changed in May 2017, when the new