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 ...

The third edition of IEC 60601-1 is filled with new and revised requirements. Particularly, manufacturers who had been operating using the second edition of the standard will find the most significant ...

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 ...

IEC 60601 is no longer a standard of absolutes. The third edition allows, and in some instances requires, safety features and test requirements to be modified on the basis of risk management. By ...

Forbes contributors publish independent expert analyses and insights. True Tamplin is on a mission to bring financial literacy into schools. Risk management is the calculated approach to understanding ...

Jea Yu has 20+ years of experience as a financial professional. He is the co-founder of Undergroundtrader.com and an author of four books. Erika Rasure is globally-recognized as a leading consumer ...