Product Details
The EU Medical Device Regulation (EU-MDR) contains mandates that are legally enforceable on devicemakers by EU member countries. It is also complex and confusing, yet you must be ready to comply by May 26, 2021.
Devicemaker’s Guide to EU-MDR makes your task easier by transforming the EU-MDR’s 17 annexes into 71 section-by-section worksheets describing the requirements, listing the tasks necessary to be compliant along with providing space for you to document the steps your organization has taken.
The worksheets are organized into 11 sections:
- General Requirements for Manufacturers
- Technical Documentation
- Technical Documentation on Postmarket Surveillance
- Declaration of Conformity
- CE Marking of Conformity
- Registration of Devices and Economic Operators
- Conformity Assessment Based on a Quality Management System and on Assessment of Technical Documentation
- Conformity Assessment Based on Type: Examination
- Conformity Assessment Based on Product Conformity Verification
- Procedure for Custom-Made Devices
- Clinical Evaluation and Postmarket Clinical Follow-Up
Click here to see a sample worksheet.
Devicemaker’s Guide to EU-MDR: 71 Worksheets for Manufacturing Compliance provides step-by-step guidance on following the manufacturing requirements for all 17 of the EU-MDR’s annexes.
Report Takeaways:
- Creating a risk-management system
- Eliminating the risk of infection
- Providing documentation for product verification and validation
- Including labeling and instructions-for-use information in technical documentation
- Understanding the requirements for active implantable devices
Order your copy today.
Who Will Benefit
- Quality control
- Regulatory affairs
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ISBN-13:
978-1-60430-143-4
Publication date:
Aug. 2020
Page count:
455
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