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Creation of design history files for medical devices

Testo Industrial Services took over the creation of Design History Files according to DIN EN ISO 13485 for medical devices for the company Sunstar. Concept development, risk analyses, GAP analyses and technical documentation were also part of the service.

Sunstar, founded in 1932, is an international Japanese company with more than 4,000 employees in over 20 countries worldwide. Sunstar offers a broad product portfolio in various product categories, such as medical devices, cosmetics, consumer goods, food and nutritional supplements, and pharmaceuticals. Medical devices developed by Sunstar GUM® for use in preventive dentistry are subject to the requirements of the Medical Devices Act and must comply with the applicable European standards.

Testo Industrial Services was commissioned with the preparation of the Design History Files according to DIN EN ISO 13485 for three medical devices from the GUM® AftaClear® group. The retrospective creation of the DHF was intended to ensure that the documentation for GUM® AftaClear® products is adapted to the requirements of DIN EN ISO 13485:2016 and that the requirements for existing products are thus also met in full. As part of this, the existing documentation was checked to ensure it was up-to-date, complete and consistent.

Ihr Vorteil: Unsere Kompetenz

  • Konzeptionierungsphase für die Erstellung der DHFs: Sichtung der Tech Files und Risikoanalysen, Festlegung Herangehensweise und der Meilensteine, Erstellung des Zeitplans
  • Prüfung der bestehenden Risikoanalysen für die entsprechenden Produkte auf Aktualität, Vollständigkeit und Konsistenz sowie Anpassung der Risikoanalysen
  • Durchführung einer Gap Analyse und Überprüfung der Tech Files auf Abweichungen und Durchführung der notwendigen Aktualisierungen und Anpassungen
  • Zusammenfassung relevanter Informationen aus den Technischen Dokumentationen in Kategorien (Design Input, Design Output, Design Verification, Design Validation, User Need, Design Transfer)
  • Erstellung von drei Design History Files für die Produktfamilie GUM® AftaClear®

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