04.01.23 -- March's Most Popular Articles & Solutions

The EU's new Directive 2022/2555 on the security of network and information systems (NIS2) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including medical device manufacturers, labs, and CROs and CDMOs.

As an integral component of product design, human factors engineering should be applied at the onset of a product-design initiative and carried out throughout the complete development process. This article shares key regulatory considerations and usability considerations for medical device packaging.

The FDA considers threat modeling fundamental in your premarket submission and expects you to include system level risks in its creation and deployment. But how do we go about threat modeling for our device? And how do we build the requisite QMS infrastructure and processes? This article shares a four-step strategy.