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 ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...

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 ...

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 ...

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FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date.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 ...

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 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 ...