Medical Devices

Medical Device industry's quality and regulatory landscape change more often than any other industry. Combined with new technologies like advanced therapies, SaMD (software as a medical device) and 3D printing, medical device companies deal with a significant challenge. QR Konnect is here to support you with existing and/or recent quality and regulatory needs.

  • MDR and MDSAP Transition
  • Medical Device Regulatory Submission (CE marking, 510(K) and Health Canada)
  • Inspection and Audit (perform internal & supplier audit and prepare for notified body audit)
  • Risk Management Compliance to ISO14971
  • Quality Management System - ISO13485 and 21 CFR Part 820
  • Design/Manufacturing Assurance
  • Labelling
  • Validation
  • Post-market Support
  • Product and Process Improvement


Location: Canada

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