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Featured Product In Submissions and Approvals

Accelerating-Generic-Drug-Development

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

$397.00
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval. Read More

Submissions and Approvals

Clinical and Performance Evaluation Under EU-MDR

Clinical and Performance Evaluation Under EU-MDR: New CE Mark Rules

$397.00
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Upgrade Your Medical Device Recall Strategy – Webinar Recording/Transcript

$287.00
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Meeting Global Unique Device Identification Requirements – Webinar Recording/Transcript

$287.00
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Data Integrity in the COVID-19 Era and Beyond — Part I: The Impact of COVID-19 – Virtual Conference Recording/Transcript

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Inspection, Measuring and Test Equipment – Webinar Recording/Transcript

$287.00
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Jon Gimbel

EU-MDR Postmarket Surveillance – Webinar Recording/Transcript

$287.00
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How to Address Medical Device Sample Size Issues – Webinar Recording/Transcript

$287.00
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Usability Engineering: How the Updated ISO 14971:2019 Changes Your Process

Medical Device Safety in the Magnetic Resonance Environment – Webinar Recording/Transcript

$287.00
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Are You Ready for ISO 14971:2019? – Webinar Recording/Transcript

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Gail Rodgers, Nancy Sims, Mason Hubbard and Adam J. Pié

Dealing with FCPA and Other Investigations Under the New Normal – Webinar Recording/Transcript

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Tom Brockhaus and Seth Mailhot

Medical Device Corrections and Removals, Recalls and Closures – Webinar Recording/Transcript

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Jon Gimbel

Implementing Clinical and Performance Evaluation Reports for Your Medical Device – Webinar Recording/Transcript

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