This oversight can be costly to the medical manufacturer in terms of product design expenses, compliance testing and certification turnaround time, and the device approval process. Medical products ...

This amendment clarifies the original intent of the third edition of the electrical safety standard, and some regulatory bodies have already started implementing it. Marco Fedeli Compliance with the ...

The IEC 60601 standards series is one part of putting together a technical file or a 510(k) submission. It’s about more than electrical safety — it covers mechanical safety, labeling and risk ...

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 ...

The IEC 60601-1standard establishes general safety requirements for all aspects of medical devices. It includes test requirements, documentation, protection from electrical hazards, protection from ...

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 ...

Magic Leap, the storied unicorn developing enterprise AR headsets, announced at CES 2023 that its flagship device Magic Leap 2 earned a certification that clears it for use in the operating room. The ...

CUI Devices has announced a line of medical buzzers compliant with IEC 60601-1-8 alarm signal requirements. There are four CPIM-4410-80x buzzers, with a letter replacing the ‘x’ depending on function: ...