BIVDA’s Regulatory Affairs Manager Neil Plumridge will present at the Excellence in Medical Device Translations: Regulatory Compliance and Beyond webinar on 30th September at 2pm to 2:45pm.
This webinar will explore best practices and service models for delivering high-quality medical device translations that meet the demands of MDR and IVDR regulations, including Instructions for Use (IFUs), SSCPs, and other regulatory documentation.
It will also address EMA-aligned regulatory translations and the linguistic validation of Clinical Outcome Assessments (COAs) in accordance with ISOQOL standards. Emphasis will be placed on aligning processes with ISO 17100 and ISO 9001 quality management systems to ensure consistent quality and compliance.
Tickets are free and you can register here.
