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 ...

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 ...

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 ...

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 ...

Build it. Develop it. Improve it. Your business needs a sustainable risk management framework that is as forward-thinking as your goals.

Risk management is the process of identifying potential risks and/or harms and creating a plan to prevent the risk from happening or reduce the risk as much as possible. There are different types of ...

What is a risk management framework? Implementing the principles and guidelines of a risk management framework (RMF) is not just an effective way to manage current risks, it also provides a structured ...

Various departments across the University of Alabama at Birmingham provide services generally related to risk management and insurance. Read the departmental descriptions below to make sure that you ...

The Risk Management Employment Claims Initiative is an education program that supports employees and supervisors in understanding employment-related issues. This program consists of four modules ...