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Both paper and digital paper are outdated approaches to medical device quality management.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.
During an outbreak, it is critical to treat reusable medical devices as potential sources of transmission.
The latest regulations for human and veterinary medicinal products, as well as medical devices, include the mandate to set up databases with detailed information about available products. These databases must be realized and implemented in the near future, and require a concerted effort now if tangible real-world benefits are to follow.
A discussion of the changing medtech markets and how companies can remain cognizant of potentially disruptive changes in their business and industry for future success in their product portfolios, services and relationships.