---
title: 'Quality Systems'
url: 'https://qualityrnconsulting.com/quality-systems-services'
markdown: 'https://qualityrnconsulting.com/quality-systems-services.md'
date: '2026-09-29'
description: '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 Letter…'
---

# Quality Systems

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

[**Request Services**](https://qualityrnconsulting.com/contact)

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