Next-generation, predictive analytic patient monitoring lowers healthcare costs, improves clinical outcomes and enhances the patient experience in hospital-at-home, post-acute care and chronic care management.
You’d think there’s not much to the concept of an alarm. A warning sounds in a room, or a red light flashes, and it has your attention. You know something must be wrong. But in a setting where a cacophony of alarming lights and sounds beset healthcare workers on a regular basis, these essential systems become increasingly easy to miss or ignore.
The long-awaited part 23 of ISO 10993, the series of standards governing Biological Evaluation of Medical Devices, was published in January 2021. It was the first to introduce validated methods for in-vitro irritation tests. This article reviews the latest developments and identifies the cases in which manufacturers can avoid animal experiments.
Building fruitful development partnerships between companies, governments and researchers will enable the most promising and impactful deployments in healthcare.
Although the future is exciting, it also poses real challenges. More collaborative initiatives need to take place between drug manufacturers and developers of manufacturing equipment and consumables.
EU regulations require manufacturers of medical devices and systems prove the single-fault safety of their products. However, it is not clearly defined in detail how to comply with these requirements. This article explains which technical and legal requirements apply and which aspects should be considered during development.
Medical device companies have upped their game in product security and regulatory compliance, but they might not be ready for a catastrophic event.
A Q&A on how device companies can respond to supply chain risks and regulations.
