ISO 14971 Certification

Third-party certification to ISO 14971 will give you added assurance that your risk management system addresses key requirements.

As a medical device manufacturer, "risk management" is likely a term you are intimately familiar with. Even so, recent changes to standards and regulatory requirements - such as ISO 13485:2003, the Medical Device Directive (MDD), and the 3rd Edition of IEC 60601-1 - now require you to demonstrate that you have a documented risk management system in place, regardless of the probability or the severity of the risk, to show that your device is safe.

ISO 14971:2007 provides a framework that you can use to develop a risk management system, helping you identify hazards, estimate and evaluate associated risks, control these risks, and monitor the effectiveness of the controls. The requirements of the standard apply at all stages of the product's life cycle, from concept through post-production.

As one of the first registrars to be accredited for ISO 13485:2003 (when documented requirements for risk management were added to the standard), and one of the first to offer certification to ISO 14971:2007, Intertek has an unparalleled wealth of experience in assessing risk management processes. When you select Intertek as your auditing partner, you can be assured that your system is robust enough to meet the demands of risk management at any point in the product life cycle.

Request more information to see how Intertek can help your organization with ISO 14971 Certification.