Medical Devices

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MEDICAL DEVICES

If you’re in medical devices, you’re constantly mindful of regulatory compliance, cost management, and more, all while being responsible for delivering results. How can you pull off a much-needed software update while keeping everything on track? You bring in an expert, is the answer.

With plenty of experience helping manufacturers of medical devices, our team will greatly ease the pain of an implementation. We’ll review your workflow, map out its integration with Epicor software, and prepare and support employees in utilizing it to full effect. The complex and sophisticated world of medical devices can use a partner like EpiCenter to ensure a seamless implementation.

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MEDICAL DEVICE CRITICAL REQUIREMENTS:

  • Regulatory compliance
  • 21 CFR Part 11
  • cGMP CFR820
  • ISO 13485
  • Recall

Medical Device Must-Haves:

  • Pre-Packaged Validation Scripts
  • Manufacturer’s Part Number
  • Device Used/Change Logs Validation
  • Consignment Inventory
  • Electronic Signature in More Places
  • ISO 13485 and 9001 Standards
  • Current Good Manufacturing Practice (CGMP)
  • CFR and FDA Requirements
  • Secure Electronic Signature & Document Control to Comply with 21 CRF Part 11
  • Non-Conforming Product Review and Tracking
  • Comprehensive Corrective Action/Preventive Action (CAPA)
  • Process/Product PQ Functionality