Why is Biocompatibility Testing of Medical Devices Critical?

Even if a material that makes up the medical device has been tested for biocompatibility, processes such as manufacturing, packaging, aging, and sterilization may have adverse effects on the material’s composition and how it reacts in different environments. Because of these potential changes, biocompatibility is an important test protocol that must be completed for every medical device end product prior to receiving global regulatory approvals. An upcoming series of seminars, organized by UL, will discu…

Continue reading →

Apps: Fun or Medical Devices?

Popularity of smartphone applications, or apps, has increased explosively. Among the implemented functionality, more and more medical device features have started to creep in. In this article, we discuss when an app is simply fun and when it needs to be regulated as a medical device.

Continue reading →

Choosing the Right Solution for Issue Management and CAPA

CAPA provides visibility into critical product quality characteristics, failures/ non-conformances, and resolutions to these issues for smarter decisions across the global, extended enterprise. With the right solution, design, manufacturing and quality improvement teams can share the same views of the information they need to directly impact Six Sigma and Lean initiatives.

Continue reading →