InfoMed

Complaint Handling and Adverse Event Reporting Software

Complaint Handling Software

 Web application

Access it from anywhere with a PC and a browser

Comes with flexible hosting options - on our servers or yours.

Contact us at info@makromed.com or 603-890-3311 x300 to conduct a convenient interactive evaluation now, using your existing PC with no demo programs or anything else to download.

InfoMed Complaint Handling and Adverse Event Reporting Software is designed to help you manage a sound customer complaints handling and adverse events reporting program. It allows you to organize, track and trend such complaints. It allows you to assess for corrective actions to mitigate these complaints. It has built-in modules to generate regulatory reporting for FDA, EUís Competent Authorities and other regulatory agencies around the world. Built in reports, trends, and much more...

General

Regulatory Compliance

  • Comply with FDAís GMP (QSR) and MDR regulations
  • Comply with European Unionís Medical Device Directives (MDD)
  • Use Decision Trees and Reporting Modules for USA, EU, Canada, Japan, and Australia
  • Meet the requirements of international quality standards such as ISO 13485
  • Full eMDR Module for AS2 submissions.

Customer Satisfaction

  • Organize and track customer complaints
  • Make corrective action assessment
  • Customer feedback through letters and reports

Product Improvement

  • Trend complaints and underlying causes
  • Generate management reports

Click here to download a brochure on InfoMed 9i Complaint Handling and Adverse Event Reporting Software.

Copyright © 2013 Makromed, Inc.