What is BS EN ISO 14155:2019?

BS EN ISO 14155:2019 is a standard that sets out guidelines for the conduct of clinical investigations involving medical devices. It provides guidance on the principles, design, conduct, recording, and reporting of clinical investigations carried out on human subjects to assess the safety and performance of medical devices before they are brought to market.

The Importance of BS EN ISO 14155:2019

With the rapid advancement in medical technology and the increasing complexity of medical devices, it is crucial to ensure their safety and effectiveness before they are used on patients. The BS EN ISO 14155:2019 standard helps manufacturers, regulatory authorities, ethics committees, and clinical investigators to carry out clinical investigations with integrity and transparency.

This standard plays a vital role in protecting the rights, safety, and well-being of human subjects involved in clinical investigations. It ensures that ethical principles are followed, risks are minimized, and the data collected during the investigation is reliable and accurate. Compliance with this standard also enhances the credibility and acceptance of the results obtained from clinical investigations.

The Key Requirements of BS EN ISO 14155:2019

BS EN ISO 14155:2019 covers various aspects of the clinical investigation process. It outlines the responsibilities of different parties involved, including sponsors, investigators, and ethics committees. The standard emphasizes the importance of obtaining informed consent from human subjects and ensures their privacy and confidentiality are protected.

The standard also provides detailed guidelines on the design and conduct of clinical investigations, including the selection criteria for participants, the methodology for data collection, and the analysis and interpretation of the results. It emphasizes the need for appropriate statistical methods and the reporting of adverse events during the investigation.

Conclusion

BS EN ISO 14155:2019 is an essential standard for the safe and effective development and evaluation of medical devices. It helps protect the rights and well-being of human subjects involved in clinical investigations and ensures the reliability and credibility of the data collected. Compliance with this standard is crucial for manufacturers, regulatory authorities, and clinical investigators to meet ethical and regulatory requirements and ensure patient safety.