Automation technologies, strategies, and applications to address the impact of dramatic regulatory change
The implementation dates for MDR (May, 2021) and IVDR (May, 2022) are fast approaching and non-compliant manufacturers are putting their EU market access at risk. These new regulatory requirements have created a “tsunami” of increased content requirements—especially in critical areas such as labeling, post-market surveillance and vigilance, software UI, marketing, and training. Manual processes and document-based systems (like Word, InDesign, and FrameMaker) simply cannot keep up.
View our sessions on topics specific to each of these critical areas and learn how automation technologies can help you weather coming MDR and IVDR content changes.