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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, 21 CFR 802, 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 13458

  • 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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