The agency stated that Battelle Memorial Institute is not in compliance with reporting requirements related to its CCDS.
Fueled by an urgent need for diagnostic testing to respond to COVID-19, the in-vitro diagnostics market is experiencing explosive growth across Asia and around the globe.
Achieving EU MDR compliance is considerably challenging for many businesses, which is why they must be discerning when it comes to selecting suitable partners.
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.
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.
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.
Monitoring patients through distributed technology will be key to restoring its health.
All industries under the healthcare umbrella should embrace each other’s capabilities because no single category of player can master it and bring to consumers all that we need and demand, says Stephen Bernstein of McDermott Will & Emery.