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Featured Product In Quality

Biological Risk Evaluation and Management for Medical Devices

Biological Risk Evaluation and Management for Medical Devices

$397.00
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards. Read More

Quality

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

$287.00
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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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Postmarket Surveillance Under EU-MDR

Postmarket Surveillance Under EU-MDR: Preparing for New Requirements

$397.00
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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

$287.00
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Devicemaker’s Guide to Quality System Change Management

Devicemaker’s Guide to Quality System Change Management

$397.00
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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

$287.00
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Tom Brockhaus and Seth Mailhot

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

$287.00
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Jon Gimbel

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

$287.00
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Preparing for the EU-MDR Audit

Preparing for the EU-MDR Audit: Understanding New Requirements and Processes

$397.00
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