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 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:
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.
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.