Fecha: Martes 30 de septiembre de 2025, de 14:00h a 14:45h.
CET
Ponente: Nataliya Nedkova

Descripción del curso: In the highly regulated world of medical devices, precise and compliant translations are not just a requirement — they are critical to patient safety and market success. 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. We 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.

Ponente: Nataliya Nedkova is a professional life sciences translator, linguistic validation consultant, and the founder of NN Translations, a boutique company specializing in medical and life science translation services since 2010. Her expertise lies in medical device translations, regulatory translations and linguistic validation services for clinical trials, with a strong focus on regulatory compliance, conceptual clarity, and patient safety. Together with her team, Natalie supports global clients across more than 180 languages, serving medical device manufacturers, pharmaceutical companies, CROs, and eCOA providers. Natalie and her team help reduce delays, support global product registration, and optimize localization workflows through ISO 17100-compliant translation and revision, final QC, terminology alignment, and multilingual DTP. NN Translations is certified under both ISO 9001 and ISO 17100, ensuring structured, auditable, and high-quality processes. Natalie brings not just services, but strategic partnership to every project she leads.

Modalidad: en directo por Zoom en el día y a la hora publicados, o en diferido durante 30 días (quienes se inscriban para participar en directo también recibirán la grabación). Solo se entregarán certificados de asistencia a quienes asistan al seminario en vivo.

Inscripción: cerrada.

Plazo de inscripción: hasta dos horas antes del evento.

Registro en la plataforma Zoom y enlace a la sala del seminario: al momento del registro, la plataforma enviará automáticamente a las personas inscritas un mensaje electrónico con los datos de acceso a la sala, y enviará dos recordatorios un día antes y una hora antes del comienzo del seminario.

Consultas generales sobre el seminario: administracion@tremedica.org