14971

ISO 14971 is the international standard for risk management in the development, production, and lifecycle of medical devices. It provides a systematic approach to identifying, evaluating, controlling, and monitoring risks related to the safety of medical devices.

Risk management under ISO 14971 covers all potential hazards, whether biological, chemical, electrical, mechanical, or software-related, and helps manufacturers ensure patient and user safety.

Importance of Compliance

Compliance with ISO 14971 is crucial for demonstrating that medical devices are safe for intended use and that any potential risks have been effectively mitigated.

It is a key requirement for meeting global regulatory standards such as CE marking in Europe, FDA approval in the USA, and other regional safety regulations.

Using this standard helps in building trust with regulatory bodies, patients, and healthcare providers by demonstrating a commitment to systematic safety.

Key Elements of ISO 14971

– Risk Analysis: Identifying potential hazards related to the medical device, including issues that may arise from both normal use and misuse.

– Risk Evaluation: Assessing the significance of identified risks based on severity and probability.

– Risk Control: Determining measures to eliminate hazards or reduce risks to an acceptable level, including product design changes, safeguards, and user instructions.

– Benefit-Risk Analysis: Evaluating whether the benefits of the medical device outweigh the residual risks.

– Risk Management Report: Compiling a final report that details all identified risks, mitigation measures, and justification for the product’s safety profile.

– Post-Market Surveillance: Continuously monitoring risk performance throughout the device’s life cycle to identify new risks and take appropriate corrective actions. Read more about post-market surveillance.

Scope of Application

ISO 14971 applies to all types of medical devices, from simple aids such as bandages to complex implantable devices like pacemakers and software as a medical device (SaMD).

The standard also covers components and accessories that could affect device safety, making it relevant not only for device manufacturers but also for suppliers and developers of medical technologies.

Steps for Compliance

1. Develop a Risk Management Plan: Define the risk management process, including roles, responsibilities, and timelines.
2. Conduct Risk Analysis: Identify hazards and potential risks throughout the entire product lifecycle.
3. Risk Evaluation and Control: Prioritize risks and establish measures to mitigate them. Controls can include design changes, protective measures, or information for safety.
4. Benefit-Risk Analysis: Document how the benefits justify the remaining risks after mitigation.
5. Documentation: Maintain a Risk Management File that contains all relevant documentation, from initial planning to final risk assessments.
6. Review and Update: Risk management is not static. Conduct post-market risk assessments and update the risk management plan to address newly identified hazards or adverse events.
7. Audits and inspections: Prepare your business on audits and inspections. Identify and correct potential discrepancies before the authorities visit.

Resources and Guidance

ISO 14971 Document: Access the official ISO 14971 standard here.

ISO TR 24971 Document: Medical devices – Guidance on the application of ISO 14971. Access the official ISO TR 24971 standard here.

Latest Updates and News

New Guidelines: The latest revision of ISO 14971, released in 2019, places greater emphasis on considering the benefit-risk balance and addresses more comprehensive post-market surveillance.

Contact Information

For help with 14971 Risk management for medical devices compliance, email us at info@scengineering.dk or use the contact form.