Medical Device Report MDR Procedure | FDA QSR Compliant

$149.00
$149.00
Unavailable
per item
The FDA Medical Device Report (MDR) Procedure describes the process used to create and submit Medical Device Reports (MDRs) to the FDA. The medical device report procedure applies to all devices marketed in the United States unless excluded by FDA regulations.
  • 21 CFR Part 803 Compliant
  • ​21 CFR Part 820 Compliant
  • ISO 13485:2016 Compliant
  • Includes Related Forms
  • MS Word Format
  • Digital Content - Instant Download
SKU: SOP 8-006

Medical Device Report (MDR) Procedure

The Medical Device Report (MDR) Procedure governs the process used to submit Medical Device Reports (MDRs) to the FDA. 

Medical Device Report (MDR) Procedure - Overview

​The Medical Device Report (MDR) Procedure applies to all devices marketed in the United States unless excluded by FDA regulations. The Medical Device Report (MDR) Procedure provides instruction on submitting MedWatch Form 3500A, report processing, electronic eMDR Submission and the Electronic Systems Gateway (ESG). 

Medical Device Report (MDR) Procedure - Compliance

The Medical Device Report (MDR) Procedure is 21 CFR Part 803, 21 CFR Part 820 and  ISO 13485:2016 compliant.
For more information about our Medical Device Report (MDR) Procedure contact us at [email protected] 

RELATED LINKS

Complaint Handling Procedure
​Complaint Handling Procedure Bundle
Vigilance Procedure
​Medical Device Quality Management System MANUFACTURING
​Medical Device Quality Management System MANUFACTURING PLUS
Medical Device Report Procedure
Medical Device Report (MDR) Procedure

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