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Risk Management International Organization for Standardization

The Volkov Law Group

Do We Really Need an ISO Standard for Internal Investigations?

The Volkov Law Group on

Call me a skeptic. Call me cynical. I understand that the International Organization for Standardization (ISO) provides valuable standardization services and guidance.  The ISO is comprised of 169 member countries....more

McDermott Will & Emery

FDA Issues Proposed Rule to Amend Medical Device Quality System Regulation

The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical device Quality System Regulation (QSR) on February 23, 2022. While FDA generally...more

Fenwick & West LLP

Let's Be Reasonable: Clearer Guidance for Minimum Information Security Standards

Fenwick & West LLP on

“Reasonable” and “adequate” seem like benign terms — until you have to litigate using them as a standard for adequate data security. Over the coming years, the definition of “reasonable security” (and the alleged failure of...more

NAVEX

Third-Party Risk Programs Should Focus on Offense, not Defense

NAVEX on

Just 43 percent of organizations surveyed in NAVEX Global’s 2016 Ethics & Compliance Third Party Risk Management Report said they evaluated third parties before engaging with them—down from 68 percent in 2015....more

NAVEX

ISO 37001: Answers to the 5 Questions We’ve Heard Most About the Standard

NAVEX on

It’s been a month since ISO 37001 was published and there are some questions we have heard percolating in the compliance world about what this means. These are the questions we’ve been hearing the most...more

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