WHAT WE PROVIDE

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

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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.

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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.

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

• EU MDR

• MDSAP

• ISO 13458

• 21 CFR 820

• Complaint Handling and Adverse Event Reporting

• Corrective and Preventive Action

• Risk Management – 14971:2019 requirements

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