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FDA and ISO Devicemaker Training Requirements
$397.00
FDA and ISO Devicemaker Training Requirements breaks down training requirements in both the FDA’s QSR and international standards ISO 13485, 9001 and 10018 — among others — shows where they overlap and where they differ and provides a plan for developing a training program that fills in all the gaps.
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UDI Direct Marking for FDA Compliance: Navigating New Rules
$197.00
Jay Crowley was the architect of UDI while at the FDA. Now a consultant advising devicemakers, he remains the go-to expert on UDI compliance. In the FDAnewsBrief, UDI Direct Marking for FDA Compliance, Crowley lays out a path to compliance.
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Supplier Quality Metrics for Devicemakers: Predicting and Selecting the Best
$397.00
In the Supplier Quality Metrics for Devicemakers management report you’ll learn how to use predictive analysis of such metrics as delivery time, management efficiency and lot acceptance rate to identify suppliers you can count on and spot potential problems in the future.
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Special Protocol Assessment: Winning FDA Support for Trial Design
$397.00
The Special Protocol Assessment: Winning FDA Support for Trial Design management report digs into the draft guidance to find vital information.
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Implementing an 11-Step Plan for Device Software Validation and Verification, 2016 Edition
$397.00
This updated edition of Implementing an 11-Step Plan for Device Software Validation and Verification contains a new chapter outlining the software validation requirements in ISO 13485:2016.
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