ISO 14155:2018 is an international standard that sets out the requirements for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical investigations carried out on medical devices.
Importance of ISO 14155:2018
ISO 14155:2018 plays a crucial role in ensuring the safety and effectiveness of medical devices. By following this standard, manufacturers can demonstrate their compliance with regulatory requirements and minimize potential risks associated with the use of their products. It provides a framework for conducting rigorous clinical investigations, which are necessary to gather clinical data and evaluate the performance of medical devices before they are released to the market.
Key Requirements of ISO 14155:2018
ISO 14155:2018 outlines several key requirements that need to be followed during the conduct of clinical investigations. These include:
Ethical considerations: The standard emphasizes the importance of obtaining informed consent from study participants and protecting their rights and well-being throughout the investigation process. It also provides guidelines for the independent ethical review of the study.
Study design and conduct: ISO 14155:2018 specifies the necessary elements of a clinical investigation protocol, such as eligibility criteria, sample size determination, investigational plan, and study endpoints. It also covers the responsibilities of the investigator, sponsor, and other parties involved in the study.
Data management and analysis: The standard requires appropriate procedures for data collection, handling, storage, and analysis to ensure the reliability and integrity of the study results. It also addresses the reporting of adverse events and the documentation of any protocol deviations.
Safety reporting and monitoring: ISO 14155:2018 emphasizes the importance of ongoing safety monitoring throughout the investigation. It sets out guidelines for reporting adverse events, managing risks, and taking necessary actions to protect the participants.
Quality management: The standard highlights the need for a comprehensive quality management system that covers all aspects of the clinical investigation process. This includes the establishment of standard operating procedures, training of study personnel, and regular internal and external audits.
Conclusion
ISO 14155:2018 is an essential standard for ensuring the quality and integrity of clinical investigations on medical devices. By adhering to its requirements, manufacturers can demonstrate their commitment to patient safety and produce reliable clinical data. Compliance with this standard not only helps companies meet regulatory obligations but also contributes to the overall improvement of medical device development and innovation.
Nina She