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Software validation is historically one of the most difficult compliance activities for life sciences companies. It’s also the single largest expense for many companies when they automate or [...]

In four months, the new EU Medical Device Regulation (MDR) goes into effect, which officially means it’s crunch time for devices that need to be certified to the new law. What should companies be [...]

With the May 26, 2021 implementation deadline looming for the new EU Medical Device Regulation (MDR), medical device companies are under pressure to ensure products are compliant with the new [...]