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.
Global travel restrictions proved it impossible to hold the event in-person.
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.
A Q&A with MedCrypt’s Axel Wirth sheds light on urgent problems that the medtech industry is facing regarding device security, but assures us that the sky is not falling.
Combining “fit, filtration and efficiency” is the key to enhancing protection and encouraging compliance.
Leveraging automation and data analytics can help facilitate innovation and financial stability.
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.