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.
A recap of a recent effort involving a small group of AIDC experts in devising a data integrity scheme suitable for protecting a new device identifier used in modern healthcare applications against mis-keying. It presents the group’s undertakings in researching solutions to ensure identifier integrity, the challenges encountered, and how a more complete understanding of the constraints of the intended application led to a departure from the initial design and resulted in the elegant solution that exists today.
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.
AdvaMed has reported that its member companies have provided $26.8 million in medical supplies, along with $4.1 million in cash donations.