COVID-19 requires us to rethink our current device disinfection procedure.
Artificial intelligence and machine learning are proving to be meaningful weapons in our arsenal during the coronavirus crisis.
Once a cost to the business, now field service is re-writing the rules for healthcare organizations.
Whatever the short- and longer-term fallout of COVID-19, organizations will need to come back fighting—with new tools at their disposal and ready to raise their game.
Timely compliance will ensure that your products will not be considered misbranded.
Being prepared significantly improves the odds that an organization will successfully manage and mitigate risk, sustain trust and loyalty, and protect and preserve their brand.
Sources of reliable data to continuously support claims of compliance by manufacturers will be in high demand in the future.
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.
Both paper and digital paper are outdated approaches to medical device quality management.
Recalls for failure are chronic in the medical device industry. The sources of those failures could originate anywhere in the supply chain. Fixing supply chain issues is ultimately the responsibility of the instrument’s maker.