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.
As medical devices using software and wireless communication become more ubiquitous, hackers are becoming more advanced in their methods.
U.S. medtech manufacturers must also prepare for the UDI requirements under EU MDR.
Although healthcare industry tends to be slow to adopt new technologies, device companies should seriously consider the potential of blockchain.
Best practices to achieve compliance as regulations evolve and customer requirements change.
Going paperless can ultimately help companies focus on improving product quality and the end-user experience.
Is your risk management process fully operational right now?
A Q&A on how device companies can respond to supply chain risks and regulations.
Identification and traceability are basic foundations associated with product realization, manufacturing, and ultimate distribution of finished medical devices. And the device world takes generally accepted identification and traceability requirements, and places them on steroids.