Medical device companies MUST have established risk management processes that comply with ISO 14971. And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. ISO ...

FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by ...

If you are still using FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date. And you might be asking why do you need to ...

ISO 14971 provides a framework for medical device manufacturers to identify and minimize risks through the design and manufacturing processes. Adhering to the standard helps ensure overall safety and ...

The EU Commission caused quite a stir in August 2012, when it announced the harmonization of the EN ISO 14971:2012 risk-management standard for the medical device industry with absolutely no ...

Medical device quality management system aligns with latest version of globally recognized risk management standard. Greenlight Guru, the only medical device quality management system (MDQMS), today ...

The US Food and Drug Administration (FDA) in late December recognized the newly revised International Organization for Standardization (ISO) risk management standard for medical devices, ISO ...

The U.S. FDA’s emphasis on internationalized regulations continues with the agency’s adoption of ISO 14971, the risk management framework published by the International Organization for ...

The U.S. FDA’s emphasis on internationalized regulations continues with the agency’s adoption of ISO 14971, the risk management framework published by the International Organization for ...

Medical Device Companies are using different tools to identify and manage the risks but some companies lack the over all process to connect the dots. This gap has resulted in several field failures ...