Quality Management System audits, implementation, gap analyses, improvement, and ongoing maintenance for compliance to:
- European Union Medical Devices Regulation (EU MDR – 2017/745)
- FDA Regulation (21 CFR 820, 21 CFR 1271, and related regulations)
- ISO 13485:2016
Resolution of:
- FDA Warning Letters, FDA 483s, Notified Body audit reports, or other authority findings.
- Corrective Action Preventative Action (CAPA) reports
- Non-Conformance Reports (NCR) findings