Approximately 1.5 million different medical devices are available globally; with thousands of new and innovative medical devices being introduced to the market every year. While there is legislation at the national and regional level ISO 14155 provides a global standard for clinical investigations on human subjects.
In this course we explore ISO-14155 in detail. ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
This International Standard specifies general requirements intended to:
• Protect the rights, safety and well-being of human subjects
• Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results
• Define the responsibilities of the sponsor and principal investigator
• Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
ISO 14155:2011 does not apply to in vitro diagnostic medical devices.
• Describe the purpose of ISO 14155:2011
• Review the respective responsibilities of Sponsors, Investigators and Ethics Committees
• State the requirements for clinical investigation planning
• Describe some practical applications of ISO 14155:2011
• Background and Definitions
• Ethical Considerations
• Sponsor & Investigator Responsibilities
• Clinical Investigation Planning and Key Documentation
• Monitoring & Oversight
• Device Accountability
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