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 ...

A risk management policy statement is a tool used by companies and other organizations to identify and respond to risks in a way that minimizes their impact. Although a risk policy statement often ...

For issues related to biological, chemical, occupational health, and radiation safety please go to UW Safety Office. For issues related to contracts, public records requests, regulations, standard ...

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 ...

What is risk? Some say risk is a nasty four letter word that can ruin your life. Risk management is serious business. As an industry, it includes over 30,000 companies and generates $6 billion in ...

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 ...