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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

Jessica Ringel -green600

Meet CDRH’s New Strategic Priorities: Where the Center is Headed and How Devicemakers Can Keep Up – Webinar Recording/Transcript

$287.00
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Pamela Forrest  -Aqua 500

Medical Device Reporting: Best Practices and Common Pitfalls – Webinar Recording/Transcript

$287.00
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Kristin Zielinksi Duggan Aqua 500

Real-World Evidence in Medical Device Submissions: What Regulatory, Compliance & Quality Professionals Need to Know – Webinar Recording/Transcript

$287.00
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Kristen Grumet - Red

FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

$287.00
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David L. Chesney Aqua 500

Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript

$287.00
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Selecting and Implementing Electronic Document Management Systems in the EU

Selecting and Implementing Electronic Document Management Systems in the EU

$197.00
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Seyed Khorashahi  - red

FDA Medical Device Inspections in the Postpandemic World: Are You Ready for New Approaches and Methods? – Webinar Recording/Transcript

$287.00
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Eric Henry - green

Medical Device Cybersecurity: Latest Developments – Webinar Recording/Transcript

$287.00
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FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

$197.00
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The MDSAP in 2022: Policies, Procedures and Developments

The MDSAP in 2022: Policies, Procedures and Developments

$297.00
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Designing Secure Medical Devices

Designing Secure Medical Devices: Building Cybersecurity into the Development Process

$397.00
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Lance Shea - green600

Statistics and Data for Regulatory Professionals and Attorneys: Product Performance Evidence Made Easy – Webinar Recording/Transcript

$287.00
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