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 ...

Project managers' tendency to focus on risks that are familiar, measurable, and controllable leaves projects vulnerable to risks. OVERVIEW: New product development projects are highly risky technical ...

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 ...

Learn how to use risk management tools and techniques to streamline medical device and diagnostic product development. Additionally, ensuring compliance with QMS requirements and guidances for ...

Risk Management is the process of identifying, assessing, and prioritizing risks followed by the application of resources to minimize, monitor, and control the probability and/or impact of adverse ...

Here are 10 of the most critical policies and procedures for reducing risk at an ASC according to Nancy Burden, MS, RN, CPAN, CPAP, director of BayCare Ambulatory Surgery in Largo, Fla., and Terri ...

As the mortgage industry continues to evolve at breakneck speed, risk management has never been a more critical lynchpin in the lending ecosystem. At the vanguard stands Mortgage Connect Risk ...

Implementing the new standard on quality management (QM) by the Dec. 15, 2025, deadline may seem daunting, but the AICPA has developed resources and tools to get started, including a recently revised ...