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 "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 ...

ITRA covers Sections 2 and 5 of the Security Standard for the Solutions Life Cycle Management (SLCM) process. You can find a link to the Security Standard: Solutions Life Cycle Management process in ...

From the first edition of The State of Risk Oversight report in 2009 to the just-released 15th edition, proactive organizational responses that recognize both the dangers of risk and the strategic ...

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.

Successful risk management is essential to the design and development of safe and effective medical devices. Unfortunately, it is too often viewed by manufacturers as an isolated activity that must be ...

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 ...

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 ...

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

Kayla Missman specializes in making complicated topics more approachable. She has eight years of experience in journalism, editing and marketing, allowing her to dive into interesting topics and ...

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 ...