As medical technology continues to evolve, so do medical device sterilization methods. Alternatives to traditional sterilization processes, including ozone sterilization are beginning to change the landscape of the medical device sterilization industry. A recent...

Labeling issues continue to plague the medical device and pharmaceutical industry. The FDA recently released a statement regarding a medication recall as a result of a labeling error. CBS News reports, “Accord Healthcare Inc. is voluntarily recalling one lot of 12.5...

Over the past decade, there has been a significant shift in medical device purchasing, pricing, reimbursement and support. Several professionals in this industry, including medical device manufacturers, health systems, as well as patients have had to adjust to the...

Human factors and usability testing professionals play an integral role during medical device design and post-market operations. In order to ensure medical devices are intuitive for HCP and patient use, human factors teams must develop safety validation strategies and...

Navigating and staying ahead of the curve in the labeling industry can be challenging. There are evolving technologies, regulations and trends to keep in mind. Manufacturing.net recently published a two-part article that explores the challenges within enterprise...

As regulatory professionals continue to adapt to EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), another challenge that many in the medical device industry face is the reality of Brexit. As a result of the changing regulations, there is...