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 ...

As a business owner, it is essential to understand the risks associated with your operations and how to manage them effectively. Risk management is necessary for long-term business success and ...

Health care in the United States is stretched to its limit, and those who enter the medical field want to be able to provide the best care possible for their patients. For nurses, usually the backbone ...

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 ...