What is EN ISO 18012:2011 ?

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 conduct clinical investigations in accordance with ethical principles and must not engage in unethical practices that may compromise the 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 gather data through rigorous monitoring and reporting of clinical investigations, ensuring that the data is accurate and reliable.

Documentation

The third requirement of EN ISO 14155:2011 is to maintain proper documentation of clinical investigations. Medical device manufacturers must document their clinical investigations, including the protocols for the investigation, the results of the investigation, and any deviations from the protocol.

Quality Management

The fourth requirement of EN ISO 14155:2011 is to maintain a quality management system that ensures the consistency and integrity of the data collected during clinical investigations. Medical device manufacturers must have a robust quality management system in place to ensure that their products are safe and effective for use by patients.

Conclusion

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