PD CEN ISO/TR 24971:2020 ExComm Overview

The PD CEN ISO/TR 24971:2020 ExComm is a pivotal technical report that addresses the essential requirements for the risk management of medical devices. Published on July 24, 2020, this document serves as a necessary guide for organizations involved in the development and application of healthcare technology, setting a comprehensive framework for ensuring the safety and efficacy of medical products.

Purpose and Importance

This technical report provides a thorough analysis of the concepts and practices related to risk management in the context of medical devices. By facilitating a common understanding of risk, it assists manufacturers, regulators, and other stakeholders in navigating the complexities of compliance with established health standards.

Key Features

• Comprehensive Guidelines: PD CEN ISO/TR 24971:2020 ExComm offers extensive guidance on the application of ISO 14971, the international standard outlining the process for risk management of medical devices.
• Harmonization: This report aids in harmonizing national and international regulations by providing clear definitions and processes, thereby promoting market access for medical devices across borders.
• Risk Management Applications: It encompasses various processes including risk analysis, risk evaluation, risk control, and the overall assessment of residual risks associated with medical devices.
• Collaborative Efforts: Developed by experts in the field, this report reflects the collaboration between different regulatory bodies and organizations, ensuring it meets high standards of accuracy and usability.

Audience

This technical report is essential reading for professionals involved in the development, regulation, and marketing of healthcare technologies, including:

• Medical Device Manufacturers
• Regulatory Affairs Specialists
• Quality Assurance Managers
• Clinical Safety Officers
• Healthcare Technology Assessors

Purchasing Information

The PD CEN ISO/TR 24971:2020 ExComm is available for purchase at £84.00. Buyers can choose between a digital PDF format or a hard copy, making it accessible for professionals seeking to enhance their knowledge in risk management practices. The ISBN for this report is 978 0 539 14678 3.

Conclusion

Investing in the PD CEN ISO/TR 24971:2020 ExComm is a crucial step for those committed to upholding the highest standards of safety and compliance in medical device risk management. Ensure your organization is aligned with leading practices by procuring this essential resource today.