MyVCM allows medical device manufacturing companies to manage both their Quality Management process AND their cybersecurity and privacy on ONE easy to use platform.

FDA Compliance     MyVCM is a cloud-based Quality Management System, designed to help you comply with FDA regulations. MyVCM helps medical device companies demonstrate good manufacturing practices and compliance with regulations, such as FDA 21 CFR Part 11 (Electronic Records) and 21 CFR 820 (Quality Systems).

Cybersecurity and Privacy    Using MyVCM, you can also manage cybersecurity in line with recent FDA Guidance  – Postmarket Management of Cybersecurity in Medical Devices.

See how mProve Health uses MyVCM to manage to FDA regulation

Manage your FDA Compliance with MyVCM

Use MyVCM to efficiently manage all Quality Management tasks involved in securing and maintaining FDA compliance:

  • Document Control and Records Management
  • Quality Management
  • Corrective and Preventive Actions (CAPA) tracking
  • Audit and Inspection Management
  • Customer Complaint Management
  • Part 11 Compliant Electronic Sign off
  • Cybersecurity Management

Reduce Your Risk of Failing FDA Audit

  • Holding patient information at any level invites risk. MyVCM helps you identify the risks and mitigate them quickly.
  • People are main cause of data breaches! Training, certification and ongoing management remain the top preventative strategies, all of which are incorporated into MyVCM.
  • Your vendors can also make you liable. Business associates that share patient information need to show compliance as well.
  • Extending the MyVCM capabilities to your suppliers helps you standardize compliance efforts.

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Reduce Your Compliance Costs

  • Standardize your entire risk and compliance program. MyVCM controls and reports are accepted across the industry as proof of compliance.
  • Reduce administrative load in ongoing tracking and maintenance. MyVCM is your compliance manager – automatically managing the day-to-day tasks of maintaining and reporting compliance.
  • Free up resources dedicated to risk and compliance tasks. MyVCM maintains checklists, communications, training modules, and reporting across the entire compliance effort.
  • Speed-up and simplify security audits or assessments. MyVCM historical and real-time reporting delivers the information required to move audits forward quickly.