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Move beyond the waterfall methodology
Think the waterfall methodology for design and development is the only compliant way to develop a medical device? Think again!
March 5, 2021
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Quick Tips: One way to add flexibility to your QMS
One problem many quality management systems have, is being too rigid. If a procedure keeps ‘getting in the way’ maybe it is time for another approach.
March 3, 2021
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Selecting and Using a Predicate Device: 5 Practical Steps
If you’re heading to the U.S. market with your medical device and can use the 510(k) program, you are going to need a predicate device
April 18, 2020
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A Quick Guide to Getting Your Device into Clinical Trails [For Researchers]
After years of development, hundreds of liters of coffee, numerous late nights and copious master and PhD theses later, you finally have a medical device
April 17, 2020
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