WEBINAR | EUDAMED MODULE 2
Asphalion expert Fran Rodríguez unveils the new challenges EUDAMED Module 2 poses.
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WEBINAR | EUDAMED MODULE 2
Asphalion expert Fran Rodríguez unveils the new challenges EUDAMED Module 2 poses.
To receive the link to the webinar, you can register here
[contact-form-7 id=”7598″ title=”Form Webinar on EUDAMED MODULE 2″]
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Asphalion expert Adi Ickowicz explores key considerations and provides valuable tips for preparing and organizing submission files to ensure a smooth and successful regulatory approval process for your medical device.
Welcome to Asphalion’s MedTech blog! Our blog aims to serve as your go-to source for regulatory insights and tips related to medical devices that we
This guidance provides recommendations to industry and FDA staff about the best practices of choosing a predicate device for a 510(k) submission. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).
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