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April 3, 2021
On a recent podcast of Quality Injection Podcast EP12, our General Manager Brian Pate spoke with Oded Assouline on the topic of US FDA Design Controls and in particular Design Input.  Some of the questions they explored were Is a concept phase needed for defining the product or device that meets the user needs. Are validation...
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Cybersecurity Review

Our cybersecurity experts can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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