Beyond the Lab: Mastering Clinical Trials with ISO 14155:2020
Medical Device Global Market Access · Pure Global
July 26, 20253m 47s
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Show Notes
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 has the role of risk management (ISO 14971) been expanded in the latest version?
• What are the new, more stringent requirements for a Clinical Investigation Plan (CIP)?
• How does the standard align with major regulations like the EU MDR?
• What is risk-based monitoring and how does it affect study conduct?
• Are there new guidelines for ethics committees and clinical audits?
• Why is public registration of a clinical trial now a critical step?
• What does "clinical quality management" mean under ISO 14155:2020?
Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.