Glossary Term
ISO 14971 (Risk Management for Medical Devices)
Definition
ISO 14971 is an international standard that outlines a risk management process for medical devices, covering all stages from design and development to production, distribution, and post-market monitoring. The standard focuses on identifying hazards, estimating risks, implementing control measures, and evaluating their effectiveness to minimize potential harm to patients, users, and the environment.
Relevance to the MedTech Industry
ISO 14971 ensures that medical devices are developed, manufactured, and maintained with a systematic approach to minimizing risks. It is critical for enhancing patient safety, fostering trust in medical devices, and achieving compliance with regulatory requirements worldwide, including FDA and EU MDR.
Additional Information & Related Terms
Key Components of ISO 14971
Risk Analysis
Identification of potential hazards associated with the device and its intended use.
Assessment of the severity and probability of harm.
Risk Evaluation
Determination of whether identified risks are acceptable based on predefined criteria.
Risk Control
Implementation of measures to reduce risks, such as design changes, protective mechanisms, or labeling.
Residual Risk Evaluation
Assessment of risks remaining after control measures are applied, ensuring they are acceptable.
Risk Management File
Comprehensive documentation of all risk management activities, serving as a key component in regulatory submissions.
Related Terms
Risk Management File: A key output of ISO 14971 that documents all risk management activities.
Residual Risk: The level of risk remaining after implementing control measures, assessed under ISO 14971.
Post-Market Surveillance (PMS): A continuous process of monitoring device risks after market release.
ISO 13485: A complementary standard requiring the integration of risk management processes into quality management systems.