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Beyond the Lab: Mastering Clinical Trials with ISO 14155:2020
This episode provides a detailed overview of ISO 14155:2020, the international standard for Good Clinical Practice in medical device investigations. We explore the key updates from the previous version, focusing on the integration of risk management, new planning requirements, and operational changes that impact how manufacturers design and conduct clinical trials. Learn what your team needs to know to ensure compliance and generate robust clinical data for global regulatory submissions. Key Questions: • What is the fundamental purpose of ISO 14155:2020 in medical device development? • How…
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