White Paper

Intelligent Automation for MDR & IVDR Content: Summary of Safety & Clinical Performance (SSCP), Summary of Performance (SSP), and Selected Labeling

Content requirements under the EU’s MDR and IVDR, including the translation of labeling, marketing, SSCPs, SSPs, and clinical communications, are set to dramatically increase. Currently, most device manufacturers use manual processes and document-based applications like Microsoft Word and InDesign to manage their content. However, manual processes and document-based approaches require additional headcount to handle increased volumes and faster turnarounds. Download our paper to learn how automation technologies (including specialized AI) can help satisfy new MDR/IVDR content and translation requirements (SSCPs and SSPs) as well as existing labeling and documentation operations—without increasing headcount!