What is EN ISO 14155:2011 ?

EN ISO 14155:2011 is an essential international standard that outlines the requirements for conducting clinical investigations on medical devices. The primary purpose of this standard is to ensure the protection of patients' rights, safety, and well-being during these investigations. To achieve this goal, the standard provides key components and requirements that medical device manufacturers must adhere to.

Key Components and Requirements

EN ISO 14155:2011 has several key components and requirements that medical device manufacturers must adhere to. These include:

1. Ethical Conduct: The standard emphasizes the importance of ethical conduct in clinical investigations, ensuring that medical device manufacturers are not solely focused on gathering data for the sake of it.

2. Reliability and Credibility: EN ISO 14155:2011 requires medical device manufacturers to gather data in a reliable and credible manner, ensuring that the data collected is accurate and can be trusted.

3. Patient Protection: The standard prioritizes the protection of patients' rights, safety, and well-being throughout clinical investigations. Medical device manufacturers must ensure that their products are safe and effective for use by patients.

4. Data Reporting: EN ISO 14155:2011 requires medical device manufacturers to report data in a clear and concise manner, making it easier for healthcare professionals to understand and interpret.

5. Documentation: Medical device manufacturers must ensure that they have proper documentation in place to support their clinical investigations. This includes records of informed consent, patient data collection, and any changes made to the product during the investigation.

Impact on Medical Device Manufacturers

EN ISO 14155:2011 has a significant impact on medical device manufacturers, as it provides a framework for conducting clinical investigations that are safe, reliable, and ethical. By adhering to the requirements of EN ISO 14155:2011, medical device manufacturers can gather essential data during clinical investigations, which can then be used to prove the safety and functionality of their products.

Conclusion

EN ISO 14155:2011 is an essential international standard that outlines the requirements for conducting clinical investigations on medical devices. By adhering to the key components and requirements outlined in this standard, medical device manufacturers can ensure that their products are safe, effective, and reliable for use by patients. By providing a framework for conducting ethical and reliable clinical investigations, EN ISO 14155:2011 plays a crucial role in ensuring the safety and well-being of patients.