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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

Digital Health Regulation

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

$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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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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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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Devicemaker’s Guide to EU-MDR

Devicemaker’s Guide to EU-MDR: 71 Worksheets for Manufacturing Compliance

$397.00
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Supplier Management for Devicemakers

Supplier Management for Devicemakers: Qualification, Contracts and Audits

$397.00
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Risk Management for Devicemakers

Risk Management for Devicemakers: New Requirements in ISO 14971

$397.00
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Evolving Quality Management Regulations

Evolving Quality Management Regulations: A Devicemaker’s Guide

$397.00
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Postmarket Surveillance Under EU-MDR

Postmarket Surveillance Under EU-MDR: Preparing for New Requirements

$397.00
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Preparing for the EU-MDR Audit

Preparing for the EU-MDR Audit: Understanding New Requirements and Processes

$397.00
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