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 ...

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 ...

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

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 ...

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 ...

The use of information systems while conducting University business bears inherent risks that may lead to breaches of confidentiality, exploitation of vulnerabilities, or other abuse of University ...

Dan Moskowitz is a financial writer who has 4+ years of experience creating content for the online reading market. Chip Stapleton is a Series 7 and Series 66 license holder, CFA Level 1 exam holder, ...

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 ...

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 ...