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Updated: Aug 8, 2026

Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices
Published on: November 29, 2024
Software validation
1EUROSPEC GmbH, Darmstadt, Germany.
Abstract:
This article examines the requirements of EN 60601-1-4, which states that risk management is an integral part of the development of software for medical devices. Food and Drug Administration regulations are also compared to the requirements of the Medical Device Directive to provide guidance on developing software for the European and US markets.
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