Intelligent Automation
AI Portal for Adverse Event/PMS Handling
Translation Automation to Meet the Increased PMS Requirements of MDR and IVDR
Device manufacturers are discovering that the MDD extension doesn’t provide as much time as first thought: an MDR-compliant QMS, including vastly expanded PMS, must be in place by May, 2024. In order to address the coming increase in vigilance reporting, manufacturers like Medtronic are turning to TransPerfect automation technologies to help them meet emerging content challenges.
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. Intelligent automation is the right solution.
