The design of medical-grade power supplies or the integration of such supplies into medical equipment has long posed unique challenges to engineers and system designers. The performance of power ...

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 ...

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 ...

UPDATE: On 13 July 2012 IEC formally published the long awaited IEC 60601-1:05 (also known as third edition) Amendment 1 (A1). It is on the IEC.ch website’s store. See below for more detail about A1.

New standards are being proposed that would change the medical-device approval process, literally turning the current method upside down. These new standards would change the method of approving ...