Medical Device manufacturers are required by the FDA to track certain types of devices from manufacture through the distribution chain to patients. The FDA released 21 CFR Part 821, which governs the requirements around the tracking process. Our DocuNECT solution is used by both large and small Medical Companies, in the cloud and on-premise and has the following features:

  • 21 CFR Part 821 Compliant Workflow Solution
  • Automated Correspondence
  • Automated E-mail/Faxing
  • Document and Image Management
  • 21 CFR Part 11 Electronic Signatures
  • Patient Data Management (HIPAA Compliant)
  • Dashboard and Management Reporting
  • Technology Transition
  • Device Disposition Audits
  • Managed Services

You can also view a video of a webinar that provides more information on the solution:

If you would like more information then contact us at: