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 ...

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 ...

Risk management is the process of identifying, analyzing, and mitigating uncertainties and threats that can harm your company or organization. No business venture or organizational action can ...

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 ...

The "An introduction to Risk Management ISO 14971:2019 Training Course (Apr 27, 2026)" has been added to ResearchAndMarkets.com's offering. Understand the use of risk management in the medical device ...

Effective risk management strategies allow you to identify your project's strengths, weaknesses, opportunities and threats. By planning for unexpected events, you can be ready to respond if they arise ...

Environmental contamination control is a crucial aspect of sterile pharmaceutical manufacturing, and risk management is needed to guarantee that the necessary control procedures are in place. The risk ...

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 ...

Risk is inherent in any business operation and good risk management is essential if you're going to identify and stop revenue leakage from your business. Of the various types of risks your business ...

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 ...

VICKSBURG, Miss. – As firefighters worked diligently to extinguish a notable number of wildfires this season, researchers with U.S. Army Engineer Research and Development Center’s (ERDC) post-wildfire ...