In 2000, the International Organization for Standardization (ISO) published a document that describes a holistic approach to understanding and controlling the risks associated with medical devices.

After years of delays from various regulatory agencies, the US Food and Drug Administration (FDA) has announced the release of a major new proposed regulation on performance standards for laser ...

Risks to a medical device’s performance can occur at any stage of the product lifecycle, as highlighted at the 2015 Risk Management Summit conducted by AAMI. Sometimes, changes in a product may be so ...

The risk of being non-compliant in the medical device industry is an expensive proposition. As of Aug. 1, FDA has initiated nearly 30 recalls during 2023 alone, the individual cost of which could top ...

Earlier this year the US followed the EU and Canada in moving to the3 rd edition of the IEC 60601-1 medical device standard. This change presents several challenges and adds layers of complexity for ...

Does your company develop electronic medical devices? IEC 60601 is different from other regulatory compliance processes and can be challenging for medical device developers in this category. You’ll ...