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Featured Product In Device Books

Selecting and Implementing Electronic Document Management Systems in the EU

Selecting and Implementing Electronic Document Management Systems in the EU

$197.00
Converting to an electronic document management system (eDMS) is key to increasing your record-keeping efficiency. Only one resource enables you to do that in a cost-effective manner while ensuring compliance with EU regulations: Selecting and Implementing Electronic Document Management Systems in the EU. Read More

Device Books

Risks of Social Media Communication

Risks of Social Media Communication: A Guide to FDA and FTC Enforcement

$397.00
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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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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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Designing Secure Medical Devices

Designing Secure Medical Devices: Building Cybersecurity into the Development Process

$397.00
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Using Real-World Evidence in FDA Submissions: A Guide for Devicemakers

Using Real-World Evidence in FDA Submissions: A Guide for Devicemakers

$397.00
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New Inspection Models

New Inspection Models: Will Your Next Regulatory Audit Be On-Site, Virtual or Hybrid?

$397.00
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Special Pathways for Innovative Devices

Special Pathways for Innovative Devices: A Guide to the FDA’s Breakthrough Device and Safer Technologies Programs

$397.00
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Digital Health Regulation

Digital Health Regulation: Navigating FDA’s Rules for Software as a Medical Device

$397.00
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Process Validation for Devicemaker

Process Validation for Devicemakers: Concepts, Methods and Models

$397.00
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The New 510(k) Pathway

The New 510(k) Pathway: A Guide to Updated Requirements

$397.00
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Reliability of Medical Devices

Reliability of Medical Devices: Ensuring Availability and Safety

$397.00
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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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