Robotic process automation (RPA) is reducing time spent on repetitive tasks in regulatory affairs and regulatory operations. The next step is artificial intelligence-enhanced RPA, which has the potential to automate more unstructured tasks.
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
Medical device recalls were up more than 31% during Q2 2020, activity that suggests recalls will reach 1200 by the end of the year, according to Stericycle’s latest recall report.
Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.
Devices in healthcare facilities support mission critical processes. Any issue that degrades network performance can have serious consequences.
Part II reviews some lessons learned as we try to predict the trajectory and defenses to COVID-19 test cases.
Part one of this series looks at the claims brought against manufacturers of diagnostic test kits.
Companies can improve their chances for a successful transition by leveraging their knowledge of their medical devices and understanding what each device’s categorization under the MDR means to its testing strategy.
New health-related data is arriving almost daily. Making sense of it all is a huge challenge.
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.