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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

Reliability of Medical Devices

Reliability of Medical Devices: Ensuring Availability and Safety

$397.00
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Breakthrough Medical Devices – Webinar Recording/Transcript

$287.00
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BREXIT’s Impact on Medical Devices – Webinar Recording/Transcript

$287.00
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Latest Medical Device Postmarket Surveillance Requirements from China’s NMPA and the U.S. FDA – Webinar Recording/Transcript

$287.00
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Data Integrity for Drug and Device Manufacturers

Data Integrity for Drug and Device Manufacturers: Avoiding Breaches and Closing Gaps

$397.00
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Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

$397.00
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Sue Schniepp Virtual Conference - blue

Data Integrity in the COVID-19 Era and Beyond — Part III: The Real-World Costs of Data Integrity – Virtual Conference Recording/Transcript

$287.00
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Get Your Combination Products to Market Faster – Webinar Recording/Transcript

$287.00
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New Adverse Event Reporting Procedures

New Adverse Event Reporting Procedures: A Devicemaker’s Guide to the IMDRF Code Transition

$397.00
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Mary Vater-Blue

FDA’s Plan for Modernizing the 510(k) Pathway – Webinar Recording/Transcript

$287.00
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Dan O’Leary - green

Reliability for Medical Devices – Webinar Recording/Transcript

$287.00
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Kalah Auchincloss - purple

Domestic Inspections and Risk Assessment – Webinar Recording/Transcript

$287.00
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