Managing regulatory requirements can be extremely challenging, especially when a company doesn’t have an existing infrastructure or significant financial backing to support the process. This could possibly lead to delayed time to market or, at worst, significant financial hardship.
In this webinar, we have invited the Head of R&D from Dynamic Code, a Sweden-based company that develops health and diagnostic tests based on advanced DNA technology, to share their firsthand experience in navigating the IVDR requirements in Europe, and how they use an electronic lab notebook as part of their digital infrastructure to support compliance and quality management needs and to bring operational benefits. They will also discuss lessons learned that could be applicable to anyone looking to start or to improve their own processes of meeting regulatory requirements.