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.
Diagnostic companies are hustling to increase availability of testing.
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Both paper and digital paper are outdated approaches to medical device quality management.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.
The Chinese government is investing heavily in the development of new technologies that leverage AI. This includes solutions to address the COVID-19 outbreak.
For medical device manufacturers, the American Invents Act created several challenges related to patent marking.
Although the medtech industry is expected to enjoy steady growth, device companies are still challenged to attract the skilled labor that manufacturing requires.
Analysts expect 2020 to be a busy year for M&A activity.