What is BS EN ISO 14155-2:2019

BS EN ISO 14155-2:2019 is a professional and technical standard that provides guidelines for the design, conduct, recording, and reporting of clinical investigations carried out on medical devices. It provides a framework for ensuring the safety and effectiveness of these devices through proper clinical evaluation.

The Importance of Clinical Investigations

Clinical investigations play a crucial role in the development and assessment of medical devices. They are conducted to gather data on the device's safety, performance, and usability in real-world scenarios. This information is vital for regulatory authorities to make informed decisions about the device's marketing approval. Additionally, it helps healthcare professionals and patients make well-informed choices regarding the use of the device.

Key Highlights of BS EN ISO 14155-2:2019

BS EN ISO 14155-2:2019 covers various aspects related to clinical investigations of medical devices. Here are some key highlights:

1. Scope and definitions: The standard defines the scope of clinical investigations and provides clear definitions for terms used throughout the document.

2. Ethical Considerations: It establishes guidelines for ensuring the protection of human subjects involved in clinical investigations. These guidelines include obtaining informed consent, addressing privacy concerns, and minimizing potential harm to participants.

3. Study Design: The standard outlines the necessary steps for designing a robust and scientifically sound clinical investigation. It emphasizes factors such as sample size calculation, selection criteria, and control groups.

4. Data Collection and Analysis: BS EN ISO 14155-2:2019 defines requirements for data collection methods, data management, and statistical analysis. It ensures that data collected during the investigation is reliable and can be used to draw valid conclusions.

Conclusion

BS EN ISO 14155-2:2019 is a comprehensive standard that provides guidelines for the proper conduct of clinical investigations on medical devices. Adhering to this standard helps ensure the safety, reliability, and effectiveness of these devices before they enter the market. It not only benefits manufacturers but also regulatory authorities, healthcare professionals, and patients in making informed decisions regarding medical device usage.