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FDA: Innovation Spoken Here

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These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S.

Canada's MDSAP Mandate Could Be Bad for Canadian Healthcare

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The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada.

Quality’s Role in Biomedical Morals and Ethics

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The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand.

Life Science Pioneer Takes Cues From 21 CFR and ISO 13485

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One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years.

Metrics: The Good, the Bad, and the Ugly

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This is the second article in a three-part series to help readers distinguish good metrics from bad. In part one we discussed good metrics.

The Difference Between Mission, Vision, Purpose, Strategy, and Goals

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Quality 4.0 in Life Sciences: Selecting Technology for Competitive Advantage

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What a difference a year and a half make. In mid-2017, LNS Research coined the term “Quality 4.0” and published definitive research on the topic.

Data Snooping Part 4

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In Part One and Part Two of this series we discovered some caveats of data snooping. In <

Use ISO 45001 to Support OSHA VPP Star Status

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Chad Kymal1 gave an excellent overview of the ISO 45001 occupational health and safety (OHS) standard that was released in March 2018.

GE’s Lessons Won’t Determine Whether You Succeed or Fail

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The news that General Electric ousted CEO John Flannery was surprising to many of us, and

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