What is EN ISO 11125-2:2011 ?

EN ISO 14155:2011 is an international standard designed to establish guidelines for the design, conduct, and reporting of clinical investigations on medical devices. The primary purpose of this standard is to harmonize the requirements for conducting clinical investigations on medical devices, ensuring the reliability and credibility of the data collected.

Key Components and Requirements of EN ISO 14155:2011

EN ISO 14155:2011 has several key components and requirements that medical device manufacturers must adhere to in order to comply with the standard. These requirements are as follows:

Ethical Conduct of Clinical Investigations

The first requirement of EN ISO 14155:2011 is to ensure ethical conduct of clinical investigations. Medical device manufacturers must ensure that their clinical investigations are conducted in accordance with ethical principles and that they protect the rights, safety, and well-being of patients.

Data Collection and Reporting

The second requirement of EN ISO 14155:2011 is to collect and report data on the safety and effectiveness of medical devices in accordance with the requirements of the investigation. Medical device manufacturers must ensure that they collect relevant data during clinical investigations and report it in a timely and accurate manner.

Documentation

The third requirement of EN ISO 14155:2011 is to maintain proper documentation of clinical investigations. Medical device manufacturers must ensure that they document their clinical investigations, including the protocols, methods, and results of the investigation.

Quality Management

The fourth requirement of EN ISO 14155:2011 is to ensure that medical devices are manufactured in accordance with the requirements of the investigation. Medical device manufacturers must ensure that their products meet the quality standards established by the investigation and that they conduct proper testing and quality control procedures.

Conclusion

In conclusion, EN ISO 14155:2011 is an essential standard for medical device manufacturers that aims to ensure the safety, effectiveness, and reliability of medical devices during clinical investigations. By adhering to the key requirements of this standard, medical device manufacturers can gather essential data during clinical investigations, prove the reliability and functionality of their products, and ensure ethical conduct of these investigations.