---
title: Services
url: 'https://qualityrnconsulting.com/services'
markdown: 'https://qualityrnconsulting.com/services.md'
date: '2026-09-29'
description: '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: FD…'
---

# Services

## 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

## Clinical & Case Management

- Clinical Research Liaison (in accordance with GCP/ICH guidelines)
- Clinical Research Consulting (full services and staff available upon request)
- RN Case Management
- Remote training/auditing for: 
    - Risk Management
    - Good Manufacturing Practices
    - Quality Management Systems
    - Complaint sample evaluation (In-house per client request)
    - Manufacturing
    - Lab/Pilot Lab/Biohazard Lab
- Post Market Surveillance
- Literature analysis review
- Internal Audits
- Manufacturing Lot Release

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

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