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 ...

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 ...

Elemental impurity risk management can help biomanufacturers to maintain regulatory alignment and ensure patient safety.

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 ...

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 ...

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 ...

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 ...

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 ...