With a plethora of standards and regulations, the development of a medical device places high demands on structure and documentation in parallel with product
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![[Von Idee und Prototyp - Die Herausforderungen aus Normen, Patientensicherheit, klinischem Nutzen, strukturierter Entwicklung, Kosten, QMS, Registrierung, Safety, Technischer Dokumentation und Business Case überwinden - um zum zugelassenen Produkt zu kommen]](https://www.ctk-medical.com/wp-content/uploads/2025/04/Medizintechnik-Herausforderungen-en.png)
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