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We provide the following Quality Assurance and Regulatory Compliance services for Medical Devices:

Remediations – Support in response to FDA warning letters and/ or ISO registrar / Notified Body Audit audit nonconformities.  Support in development of quality processes and procedures in compliance with QMS requirements.

Gap Assessment and Auditing – Evaluation of QMS system to requirements of ISO 13845:2016, 21 CFR 820, 803 and 806 as well as MDSAP and EUMDR.  Performance of required Internal Audits as an external auditor.

Training - Tailored to your specific company needs on various Medical Device QMS topics including but not limited to:

  • EU MDR


  • ISO 13485:2016

  • 21 CFR 820

  • Complaint Handling and Adverse Event Reporting

  • Corrective and Preventive Action

  • Risk Management – 14971:2019 requirements

Staffing Support – Interim Head of Quality/Management Representative or other roles as needed

Services: Text
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