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.
Use ISO 45001 to Support OSHA VPP Star Status
Chad Kymal1 gave an excellent overview of the ISO 45001 occupational health and safety (OHS) standard that was released in March 2018.
Occupational Health and Safety: A Standard Approach
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An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–requirements” replaces OHSAS 18001 as the primary OH&S standard used intern
Applying the Procedures of MIL-STD-105 to Imaginary Limits
In my first article, the merits and cautions of AS9138 c=0 sampling plans were discussed and a simple formula was provided to determine the required sample size to d
Using MIL-STD-105 As a Process Control Procedure
In my previous article, I discussed the merits and cautions of the “acceptance number” equal zero (c=0) sam
Supplier Development Over the Years
Omnex began working in the automotive industry by assisting Ford powertrain suppliers in 1986. The U.S. automotive industry’s Big Three used GM’s Targets for Excellence, Ford’s Q 101, and Chrysler’s SQA standards to qualify its supply bases.
