The center intends to facilitate partnerships, exchange knowledge and promote innovative regulatory approaches.
The non-profit organization states that 60–70% of KN95 masks tested do not filter 95% of aerosol particulates.
Achieving EU MDR compliance is considerably challenging for many businesses, which is why they must be discerning when it comes to selecting suitable partners.
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.