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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

Process Validation: A Guide for Devicemakers

$397.00
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FDA to Scrutinize Essure Implant’s Safety Record

$40.00
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Devicemakers Forge Program to Accredit Global Suppliers

$40.00
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Effective Internal Audits and Quality Control Units for Devicemakers

$397.00
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Unique Device Identifier (UDI) Rule Implementation and Compliance Guide

$397.00
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6 Steps to a Stress-Free eMDR Rollout

$397.00
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Using ISO 11607 to Develop Risk-Based Device Packaging

$397.00
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China Issues 90 Standards to Raise Device Quality

$40.00
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IMDRF Proposal Explains Use of QMS for Device Software

$40.00
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Lensmaker’s GMP, CAPA Violations Bring Warning Letter from FDA

$40.00
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FDA Warns GVS Filter Technology on Testing, Quality Violations, CAPA

$40.00
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Data Integrity Compliance

$257.00
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