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.
In general, the Asian markets have controlled the COVID-19 virus successfully outside of China, but its effect has still led to new developments and trends.
The FreeStyle Libre 2 now has indications for children ages four and older.
The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
Smart process automation promises to cut complexity and transform product traceability in the medical device industry. However, its potential relies 100% cent on having good, reliable data on which to draw.
Timely compliance will ensure that your products will not be considered misbranded.
With the Covid-19 pandemic increasingly forcing healthcare testing, diagnosis and treatment online, the promise of augmented and virtual reality is drawing deepening interest in Asia’s medtech market.
Sources of reliable data to continuously support claims of compliance by manufacturers will be in high demand in the future.
As the saying goes, if it looks too good to be true, it probably is.
Taking a bare-minimum approach to meeting the eIFU requirements of EU MDR could mean missing an opportunity to improve transparency in healthcare. Here’s how to use eIFU to provide stakeholders with greater confidence and clarity in medical devices.