ISO 14971

ISO 14971 is the international standard for risk management in medical device companies; this 9-part document establishes guidance for risk analysis, evaluation, control and management, and specifies procedures for review and monitoring during production and post-production.

The latest medical device regulations in Europe place a strong emphasis on risk management throughout the product lifecycle for medical device companies. Manufacturers need to mitigate risk throughout the design and production process, but the risk management process no longer ends when the product ships to the customer. ISO 14971 compliance requires that companies manage risk as an ongoing internal process that spans the entire product lifecycle.

The requirements of ISO 14971 are harmonized with the latest Medical Devices Regulations (MDR), Europe's latest medical device compliance regulations. The new emphasis on risk management in quality systems means that manufacturers compliant with ISO 14971 are already ahead of the game when it comes to accessing the European marketplace.

Risk Management Standards Are Enacted Throughout The Product Life Cycle

Risk management ties in closely with the product development process at your medical device company - after all, what better time could there be to identify and guard against risks?

Developing and executing your risk mitigation policy in conjunction with your design controls is an effective means of ensuring that you're thinking about and addressing the risks associated with your medical device long before it reaches the marketplace. Here's how to sync up your efforts for optimal results:

  • Plan Your Product and Risk Management Strategies Together - Develop a project plan that puts product development and risk management side by side. If you start thinking about risk once your product is already finished, you'll miss out on plenty of ways that it could have been improved.
  • Integrate Product Development with Systems Risk Analysis - As you design your product, proactively manage risk by conducting systems risk analysis. Are you building sources of risk that can be mitigated? How can you modify your design to reduce the risks and hazards it presents to the end user?
  • Sync Up Your Design Validation and Risk Management Report - As part of your design control process, you'll be conducting a design validation step to ensure that your medical device meets the defined design inputs and design outputs that you developed. At this time, you should also be able to write your risk management report, showing that you've assessed the risks associated with your medical device and found that the medical benefits outweigh the risks for your device.

Once you release your product to the market, production and post-production risk management will become the focus of your risk management activities. Customer complaints and feedback, your CAPA process, internal audits, QA processes and other aspects of your overall QMS all feed into risk management. You should continuously revise your risk management report to reflect new risks that you learn about through these avenues.

Greenlight Guru's QMS Software Supports The Effective Implementation Of ISO 14971

The risk management process described in ISO 14971 is meant to span the entire lifecycle of your product, from product development to the end of the product's usable life. Risk management produces plenty of documentation that needs to be securely stored, backed up, and accessible for reference and review at all times. Greenlight Guru's QMS Software creates a "single source of truth" that contains all of the most important, up-to-date information on your risk management process.

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Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your quality processes with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →


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