EU MDR: Ensuring Labeling Compliance In July 2023, the European Parliament granted an extension to the new European Union Medical Device Regulation (EU MDR). This extension acknowledges the challenges that have arisen due to slow market readiness and lack of notified bodies, and grants companies additional flexibility to meet the demand for safe, innovative …
E-labeling: The Road to Reduced Medical Device Packaging Material In the consumer world, it’s now common practice to access product information online. For detailed instructions or information about manufacturing practices, safety advice and so on, users can scan a QR code or go to a web address, which takes them to the latest details, …
E-labeling: The Road to Reduced Medical Device Packaging Material Read More »
How Real-World Evidence Helps Medical Device Manufacturers Drive Value Real-world evidence (RWE) captured during the testing phase for medical devices and during the post-approval period helps key stakeholders understand the clinical outcomes that can be achieved by using a particular device—including by population. RWE also offers important opportunities to ensure medical devices are used …
How Real-World Evidence Helps Medical Device Manufacturers Drive Value Read More »
Why Human Factors Engineering Matters in Medical Device Packaging Human Factors Engineering (HFE), also referred to as Usability Engineering (UE), is the application of knowledge about human behavior, abilities, limitations and other characteristics of medical device users that are applied to the design of medical devices. These characteristics include mechanical and software-driven user interfaces, …
Why Human Factors Engineering Matters in Medical Device Packaging Read More »
Life Sciences Labeling for Patient Safety Labeling regulations from the FDA and European Union (EU) are continuously changing to protect public health and improve patient safety. The Drug Supply Chain Security Act (DSCSA) enhances FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. These …
Device Labeling: Best Practices EU MDR required companies to make significant changes to their medical device labels, highlighting the need for a well-coordinated and agile device labeling process. We spoke with Laura Johnson, director of sales with Loftware, an enterprise labeling and artwork management provider, to discuss common pain points in label development and …
