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ISO 13485 Consulting Services

ISO 13485 Consulting Services for Medical Device Quality Management Systems

Experience the Quality Resource Center Difference – Mark Bringolf, CEO Platinum Imaging says “Dan and the QRC team did an excellent job steering us through the ISO certification process. We achieved the ISO 13485 as well as 9001 in approx. 9 months. Great follow up and communication throughout the process.”

Quality Resource Center has been providing ISO 13485 consulting services for over a decade to medical device manufacturers and service providers to meet customer and regulatory requirements.

Quality Resource Center offers minimal disruption of your present day to day operation. Quality Resource Center’s ISO 13485 Consultants recognize that you must continue to run your company at the same time you are setting up the ISO 13485 Medical Device Quality Management Systems and our time tested approach makes this possible.

Our Record of 100% First-Time Certification – Companies using QRC’s experienced ISO 13485 Consultants and our full-service implementation program have received certification following their first audit by a Registrar. A record of unmatched success that separates us from all other competitors.

Quality Resource Center’s ISO 13485 Consulting Services include:

  • Turnkey System Design
  • Project Management
  • Outsourced Internal Audits
  • ISO 13485 Internal Auditor Training and Certification
  • Management Representative Training and Certification
  • Process & Interactions Mapping
  • Policy Development
  • Key Process Indicator Development
  • CFR 821 compliance
  • Implantable Devices
  • Firmware Management
  • Risk Management including D and P FMEA
  • Product ID Management
  • Process and Product Verification & Validation

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If you’re considering ISO 13485 Certification

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Companies generally report that Quality Resource Center’s quoted cost is significantly less than it would cost them to do the work themselves.