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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 Deutschland GmbH. 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, together with its completeness and consistency.

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  • Conceptual design phase for the creation of DHFs: Review of tech files and risk analyses, definition of approach and milestones, preparation of schedule
  • Review of the existing risk analyses for the corresponding products for up-to-dateness, completeness and consistency as well as adjustment of the risk analyses
  • Perform gap analysis and review tech files for discrepancies and make necessary updates and adjustments
  • Summary of relevant information from the technical documentation in categories (Design Input, Design Output, Design Verification, Design Validation, User Need, Design Transfer)
  • Creation of three design history files for the GUM® AftaClear® product family

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