How ISO 13485 & EU MDR Impact Medical Device Translation Compliance

Medical device manufacturers and life sciences organizations face increasing regulatory and translation challenges under the EU Medical Device Regulation (EU MDR). In this expert webinar, Seprotec explores how ISO 13485 and EU MDR requirements impact multilingual documentation, labeling compliance, and translation workflows across the medical device lifecycle. Join industry specialists Teresa Gómez Manzano (SGS International Certification Services Iberica), Rocío Fernández Huertas (Seprotec), and Carla Konzel (STERIS) as they discuss regulatory compliance, ISO 13485-certified translation processes, standardization and harmonization practices, and the importance of working with qualified language service providers in highly regulated environments. Key topics covered in this webinar include: What the EU MDR means for medical device manufacturers and suppliers ISO 13485 requirements and quality management systems Translation workflows aligned with regulatory compliance Medical device labeling and multilingual documentation Best practices for life sciences translation and localization Lessons learned from global healthcare industry experience This webinar is designed for professionals working in medical devices, life sciences, regulatory affairs, quality assurance, compliance, localization, and multilingual content management. To learn more about Seprotec’s medical and life sciences translation solutions, visit: https://seprotec.com/ Follow Seprotec for more webinars and industry insights:   / seprotec-multilingual-solutions   #EUMDR #ISO13485 #MedicalDeviceCompliance #LifeSciences #MedicalTranslation #RegulatoryAffairs #Localization #Seprotec