Risks to a medical device’s performance can occur at any stage of the product lifecycle, as highlighted at the 2015 Risk Management Summit conducted by AAMI. Sometimes, changes in a product may be so ...

As every compliance practitioner is well aware, even in 2023, third parties still present the highest risk under the FCPA. The 2023 ECCP devotes an entire prong to third-party management. It begins ...

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 ...

Once the risk team has been assembled, the crucial process of identifying risks must commence. The output of the risk ...

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 ...

NEW YORK — August 11, 2020 — Wayne Penello, President and founder of Risked Revenue Energy Associates (R^2), and R^2 Managing Director Andrew Furman, today announced the publication of Risk Is an ...

Enterprisewide risk management systems have expanded greatly in recent years, primarily as a tool to help management and the board proactively deal with emerging risks. While the entity’s approach to ...

From fires to employee errors, all businesses face risks. Starting a business without risk is impossible, so to run successful businesses, small-business owners must understand and prepare for the ...

University of Colorado Boulder is committed to managing its risks proactively, holistically, and ensuring that risk management is an integral part of all university activities and a core capability.

Chemical process industries face inherent risks arising from the manipulation and storage of hazardous substances, complex process operations, and the potential for catastrophic chain-reaction events.

The Army is launching Project Sentinel to adapt the current Risk Management Framework (RMF) process into a streamlined threat-informed risk decision process. The Army adopted the Risk Management ...

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 ...