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ISO 14001, ISO 50001 Benefit the Environment and the Bottom Line

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The U.S.

Historic Vote Ties Kilogram and Other Units to Natural Constants

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A convocation of delegates representing 60 countries voted last month in Versailles, France, to implement the most significant change to the International System of Units (SI) in more than 130 years.

Five Role-Model Organizations Win 2018 Baldrige National Quality Award

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The U.S. Department of Commerce announced that the 2018 Malcolm Baldrige National Quality Award will be given to two educational institutions, an organ donor group, a hospital, and a project management firm.

Inside Quality Digest Live for Nov. 16, 2018

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In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.

The Benefits of a Connected Quality Platform

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BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapi

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.

Top Five Things Life Science Companies Need to Know about ISO and FDA Requirements

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Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails.

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