WHAT WE PROVIDE
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:
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