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As originally asked by Brad Brenner. Jennifer Finetti Communications | Writing | Advocacy | Marketing | Outreach for Education / Higher Ed, EdTech and more Marketing and promotion of off-label uses is strictly prohibited and highly regulated. The onl...
As originally asked by Graham Ball. The company I am working with supply a part which is built into monitoring and control devices used in the medical field. None of the devices are implanted in any way. Our customer supplies the final product to the...
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Perry Mykleby Customer Activation, Engagement & Retention ISO13485 is a quality standard that helps assure that customers get well-designed, needed, products that operate safely and as advertised, and that systematic feedback about the product will ...
Surgeon's Criticism of FDA Echoed in Senator's Book It's the situation we all dread: A device with an obvious market and strong evidence of effectiveness bogs down in a seemingly endless FDA approval process. According to Colorado surgeon Dr. Robert ...
As originally asked by Mark Driscoll, P.Eng., Ph.D. Please share with me your experiences in acquiring the 13485 certification. More specifically, for a start-up medical device company, is it advisable to move through the process internally or hire e...
As originally asked by Olufemi Adeoye. Can someone provide me with estimates on how much ISO 13485 registrar (CMDCAS for Canada) and EU notified bodies charge for certification as well as how long it takes; considering 1) Specification developer/Auth...
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