What is EN ISO 14155-2:2011 ?

Title: Understanding EN ISO 14155-2011: The International Standard for Clinical Investigation of Medical Devices

EN ISO 14155:2011 is an essential international standard that outlines the requirements for conducting clinical investigations on medical devices. This standard was developed with the primary goal of ensuring the protection of patients' rights, safety, and well-being during these investigations. EN ISO 14155:2011 is a crucial tool for medical device manufacturers to gather essential data during clinical investigations, proving the reliability and functionality of their products.

Key Components and Requirements

EN ISO 14155:2011 is composed of several key components and requirements that medical device manufacturers must adhere to in order to comply with the standard. These components include:

This section provides an overview of EN ISO 14155:2011, its importance, and the key requirements that must be met.

Purpose: This section explains the primary purpose of EN ISO 14155:2011, which is to harmonize the requirements for conducting clinical investigations on medical devices, ensuring the reliability and credibility of the data collected.

Key Requirements: This section delves into the key requirements of EN ISO 14155:2011, including the requirements for the conduct of clinical investigations, the collection of data, and the reporting of results.

Impact on Medical Device Manufacturers: This section discusses the impact of EN ISO 14155:2011 on medical device manufacturers, including the benefits and challenges that the standard presents.

Conclusion

EN ISO 14155:2011 is an essential international standard that outlines the requirements for conducting clinical investigations on medical devices. By adhering to this standard, medical device manufacturers can gather essential data during clinical investigations, proving the reliability and functionality of their products. By following the guidelines outlined in EN ISO 14155:2011, medical device manufacturers can ensure the safety and effectiveness of their products, while also ensuring the ethical conduct of clinical investigations.