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.
The agency is seeking solutions to rapidly address public health needs related to the pandemic.
A snapshot of some key technologies affecting how medical professionals practice.
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.
Combining “fit, filtration and efficiency” is the key to enhancing protection and encouraging compliance.
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.
Part II reviews some lessons learned as we try to predict the trajectory and defenses to COVID-19 test cases.