IEC 60601-1 unveils additional dimensions through its concepts of Basic Safety and Essential Performance. In this article, we'll explore these distinctions to provide clarity and insight.
Has your compliance department considered the European Deviations required for IVD devices?
Is it time for your company to consider adding Medeq Consulting, LLC to it's external talent cloud?
In the rapidly evolving landscape of medical technology, ensuring the safety and efficacy of medical devices are paramount.
In the intricate world of medical device manufacturing, ensuring compliance with stringent regulations is not just good practice—it's a legal necessity. Compliance engineering is at the fo...
In the ever-evolving landscape of medical device manufacturing, adherence to global standards is not just a recommendation; it's a prerequisite. The CB Scheme (Certification Body Scheme) and...