Medical Device Reporting (MDR)


The management of medical device reporting (MDR) processes is essential for compliance with FDA regulations and equally essential for good business practice and improvement.

Regarder la vidéo associée
Télécharger les ressources gratuites

Product Information

Discover how MasterControl software can manage your processes, all while mitigating risk, improving speed-to-market, and generating ROI.

Product
Product Data Sheets

Toolkits & Demos

Get in-depth, comprehensive resources to guide development of your programs and processes.

Interactive and Live Demonstrations
Interactive and Live Demonstrations
Toolkit
Toolkits

Educational Materials

Get insider information about the most relevant issues, and how to navigate and overcome the complexities of FDA regulations.

Interactive and Live Demonstrations
White Papers
Infographics
Infographics
Analyst Reports
Analyst Reports

MasterControl Software Solutions for Medical Device Reporting

MasterControl recognizes that the essence of medical device reporting management is controlled MDR data, the ability to track status, and streamlined quality processes. The MasterControl Process solution, for example, provides data control and reporting while simultaneously streamlining quality processes by providing the following features and benefits:

  • MDR Forms (e.g., Medwatch Form 3500A) that can be populated electronically and automatically routed to pre-approved viewers/approvers.
  • Electronic MDR forms can provide fields with drop-down menus for easy selection of common information, making data entry faster and more accurate.
  • Industry standard HTML forms design platform simplifies printing and provides a familiar interface to users.
  • Automatically generates audit trails that can be useful during audits, etc.
  • Optional configuration with the MasterControl Customer Complaints and MasterControl CAPA solutions both of which can automatically generate a task for the completion and approval of an MDR if warranted.

MasterControl Medical Device Reporting Services

MasterControl provides the following services:

  • Implementation
  • Training
  • Support technique
  • Validation
  • Gestion de projets

For More Information on Medical Device Reporting

To learn more about the software solutions that can streamline medical device reporting (MDR) processes, please feel free to contact a MasterControl representative.