PD CEN ISO/TR 24971:2020

Comprehensive Risk Management for Medical Devices

PD CEN ISO/TR 24971:2020 is the essential technical report for implementing ISO 14971, the international standard for medical device risk management. This British Standard provides detailed guidance on all aspects of the risk management process, helping manufacturers ensure the safety and efficacy of their products.

Ensure Compliance and Patient Safety

Compliance with ISO 14971 is a regulatory requirement for medical devices in most major markets, including the EU, US, and Japan. PD CEN ISO/TR 24971:2020 acts as a comprehensive implementation guide, enabling you to:• Identify and evaluate potential risks associated with your medical device• Implement effective risk control measures to mitigate those risks• Continuously monitor your device's safety throughout its lifecycleBy following the guidance in this technical report, you can demonstrate compliance with the latest risk management regulations and give patients the confidence that your devices are safe and effective.

Comprehensive Risk Management Guidance

PD CEN ISO/TR 24971:2020 covers all aspects of the ISO 14971 risk management process, including:• Risk analysis - Identifying potential hazards - Estimating and evaluating risks• Risk control - Implementing risk reduction measures - Residual risk evaluation• Risk management review and reporting - Continuous risk management activities - Documentation and record-keepingThe report also provides valuable information on related standards, the regulatory landscape, and emerging risk management best practices. Whether you're new to ISO 14971 or looking to optimize your existing risk management system, this technical report is an essential resource.

Key Benefits:

• Ensure compliance with ISO 14971 and other medical device regulations• Protect patient safety by identifying and mitigating potential risks• Streamline your risk management processes for greater efficiency• Demonstrate a robust, documented approach to regulators and stakeholders• Stay up-to-date with the latest risk management standards and best practicesWith its comprehensive coverage and practical guidance, PD CEN ISO/TR 24971:2020 is an indispensable tool for any medical device manufacturer or designer. Invest in this essential British Standard to safeguard your products, your patients, and your business.