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Medical Device Risk Management and Assurance –
ISO 14971

Oriel STAT A MATRIX can help your company craft an effective risk management program and satisfy the demands of ISO 14971.

Overview

ISO 14971, an international standard for risk management in the manufacturing of medical devices, provides the foundation for a strong risk management program.

ISO 14971 is recognized by the US Food and Drug Administration (FDA), European authorities, Health Canada, the Australia Therapeutic Goods Administration, and other regulators as the “de facto” standard for risk management. Outlined in ISO 13485 (the ISO quality management standard for medical devices), ISO 14971 is an integral part of an effective quality system. It should be incorporated into the life cycle process of medical device manufacturing.  In addition, there is an increased focus on risk management in the ISO 13485 revision.

The purpose of ISO 14971 is to establish, document, and maintain a risk management process to:

  • Review the intended use of a medical device.
  • Identify hazards and estimate the probability that harm might occur.
  • Estimate the severity of each hazard and evaluate the associated risks.
  • Control the risks and monitor the effectiveness of the controls put in place.

A solid risk assessment program helps device manufacturers identify design issues before distribution, eliminating dangerous problems and the costs associated with recalls. But achieving compliance with ISO 14971 can be a challenge. The standard requires companies to review the risks posed by a product over time and monitor any changes (e.g., design changes, customer input/feedback, and post-market surveillance). This level of risk assessment requires careful planning and an infrastructure to support the activities. Oriel STAT A MATRIX can help your company develop and implement the needed processes efficiently and correctly, as well as provide a valuable outside perspective on your risk management practices.

Consulting

Leverage our medical device sector expertise. Our medical device industry experts have practical experience applying risk management practices within medical device manufacturing. They will help you devise an effective risk management program that works with your company’s business operations.

Oriel STAT A MATRIX’s medical device team can help your company:

  • Plan an effective risk management program and establish processes to support the program.
  • Identify hazards and estimate the probability that harm might occur.
  • Estimate the severity of each hazard and evaluate the associated risks.
  • Control risks and monitor the effectiveness of the controls put in place.
  • Evaluate the risk posed by changes as the design evolves.
  • Integrate ISO 14971 into an existing ISO 13485 and/or FDA GMP quality management system.

Why choose Oriel STAT A MATRIX as your ISO 14971 consultants for medical device risk management?

Oriel STAT A MATRIX’s consulting team has implemented hundreds of FDA GMP and ISO 13485 quality systems at medical device companies making a wide range of Class I, II, and III devices. Our industry experts are skilled at identifying and reducing risk in all types of devices and processes, and they have extensive experience integrating ISO 14971 into existing ISO 13485 and FDA GMP quality management systems.

Get more from your ISO 14971 initiative.

Oriel STAT A MATRIX is a leading worldwide consultant in Performance Excellence. We will integrate our regulatory compliance recommendations into your company’s existing continual improvement processes. Our goal is to help you develop a system that will withstand an audit and enhance your overall quality, productivity, efficiency, and profitability.

Create an internal risk management team. Send your team to our training course: Risk Management and Analysis for Medical Devices.

Select a course below to learn more or to register.
 
Course Name Public On-site
Risk Management for Medical Devices: ISO 14971

This course covers ISO 14971:2012 (and key distinctions from the 2007 version) and the application of risk management practices throughout a product's full life cycle. Includes coverage of ISO 13485:2016. Click to learn more.

Provided below are a variety of practice related white papers, market updates and case studies.

Updated! The New ISO 13485: Major Changes Your Organization Must Address

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