ISO 14971 Standards

ISO Standard for Medical Device Risk Management

ISO 14971 is the ISO standard for risk management specifically for medical devices. It's a framework designed specifically for medical device manufacturers to use in developing and maintaining a risk management system. Risk management is a structured application of policies, procedures, and practices for analyzing, evaluating, and controlling risk.

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Benefits of ISO 14971

The ISO 14971 standard helps you establish a systematic process for managing the risks involved with medical device usage. The following are the key benefits of the standard:

  • Enable more efficient risk management planning.
  • Establish effective methods of reducing risk for all medical device stakeholders and patients.
  • Ensure the safety and effectiveness of medical devices.
  • Streamline regulatory processes that will enable entry into various global markets.
  • Have more confidence in audit preparation.

Medical Device Risk Management Process

Establish a Risk Management Framework: Risk management should be a thoroughly planned, documented, and proactive process for improving a product’s design and usability during and after product design and development.

Identify Hazards: Hazards are defined as potential sources of harm to a patient or consumer from using a device.

Identify Hazardous Situations: Hazardous situations are circumstances in which people, property, or the environment are exposed to hazards.

Estimate Risk: Once hazards and hazardous situations are identified, estimate both the probability of occurrence and the potential severity of hazardous situations.

Evaluate Overall Acceptability of Identified Risks: ISO 14971 requires that risks are reduced as far as possible (AFAP). Create a risk acceptability matrix to determine if the identified risks are acceptable, if the benefits outweigh the potential risks, or if risk mitigation is required.

Establish Risk Control Measures: Under ISO 14971, it is a requirement to implement measures for controlling all risks, not just those that are unacceptable.

Risk Management Report: After completing the risk management processes, prepare a risk management report before beginning production on the device.

ISO 14971 Certification

To maximize the effectiveness of your risk management system, it’s important to ensure that your processes meet the requirements for ISO 14971 compliance. In addition to applying risk management practices, being familiar with other ISO standards can be valuable in developing safe and effective medical devices.

ISO 14000 series – Provides practical guidance for managing manufacturing challenges regarding the environment. ISO 14001 is the most critical standard in this series. It specifies the requirements of an environmental management system (EMS) for organizations of all sizes.

ISO 13485 – An internationally-accepted standard for a quality management system specific to the medical devices industry.

Risk Management Key Terms and Definitions

The ISO 14971 standard provides a comprehensive list of terms and definitions relating to risk management. The following is a list of the most common terms:

  • Risk Management – Systemic application of management policies and procedures for analyzing, evaluating, and controlling risk.
  • Risk – Combination of the probability of occurrence of harm and the severity of that harm.
  • Hazard – Potential source of harm.
  • Hazardous Situation – Circumstances in which people, property, or the environment are exposed to one or more hazards.
  • Risk Control – Process for making decisions and implementing measures to reduce and maintain risks within specific levels.

ISO 14971 Software Automates Compliance

MasterControl’s automated solutions help medical device manufacturers streamline compliance with ISO 14971 by unifying all risk-related activities and documentation in a single, centralized repository. Engineering and manufacturing staff can document and store risk mitigation activities throughout the product lifecycle.

  • Document Control – Easily manage risk-related documentation and automatically route documents along processes designed for each level of evaluated risk.
  • Risk Management Plan and Reports – MasterControl provides an audit trail for every change made to a company’s risk management plan and automates the reporting of risk management issues and data.
  • Risk Assessment – Configure multiple risk types for evaluating different categories of operational risk. Launch risk assessments from anywhere within MasterControl to analyze hazards associated with any process or activity.
  • Integration – Launch and track risk-related activities from any MasterControl module. Risk assessments launched from an item (document, process, project, bill of materials, etc.) are automatically linked to all related MasterControl system processes.

QMS Provider for the FDA

MasterControl solutions are used by the most trusted leaders in life sciences and manufacturing industries. Since 2009, the U.S. Food and Drug Administration (FDA) has been using a variety of MasterControl’s Quality Excellence™ solutions to improve the quality processes of the Office of Regulatory Affairs (ORA) and the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).