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FDA Quality Management Systems (QMS) for Medical Device Manufacturers

Oriel STAT A MATRIX helps medical device and IVD companies of all sizes comply with the FDA Quality System Regulation (21 CFR Part 820). Our team can help you implement a new FDA-compliant QMS from the ground up or maintain your current compliance using FDA mock inspections and/or internal audits.



Let Our QMS Team Answer These Key Questions for You…

  • How do we get started implementing a QMS?
  • Can we implement a new QMS in stages?
  • How long will it take and what resources will be required?
  • Do we need to comply if we outsource all manufacturing?

Our Staged Approach to FDA QMS Compliance

You can read the entire FDA QSR in less than half an hour but – unless you have someone who knows how to interpret FDA’s deceptively simple requirements – you’ll spin your wheels figuring out where to begin and how to comply. We’ve helped 1,000+ medical device and IVD companies with QMS compliance, so we know what it takes to comply with the FDA QMS regulations. We also know that growing companies are stretched thin, which is why we developed a phased approach that makes the transition to FDA compliance achievable.

Phase 1: Assess and Plan We will perform a baseline assessment to determine your current level of compliance with the FDA Quality System Regulation (QSR), examine opportunities for improvement, and present a clear path forward that includes all resources needed and a timeline

Phase 2: QMS Implementation We prepare a responsibility matrix for applicable QSR clauses, create a process map of your organization’s workflow, develop/modify procedures, write quality policies, document work instructions, train all personnel, perform a preassessment, and help you make corrections as needed

The Oriel STAT A MATRIX Medical Device QMS Implementation Process


FDA Quality System Regulation (21 CFR Part 820) Sections

Subpart A: General Provisions

Subpart B: Quality System Requirements

Subpart C: Design Controls

Subpart D: Document Controls

Subpart E: Purchasing Controls

Subpart F: Identification and Traceability

Subpart G: Production and Process Controls

Subpart H: Acceptance Activities

Subpart I: Nonconforming Product

Subpart J: Corrective and Preventive Action

Subpart K: Labeling and Packaging Control

Subpart L: Handling, Storage, Distribution, and Installation

Subpart M: Records

Subpart N: Servicing

Subpart O: Statistical Techniques

Compliance With ISO 13485

If your ambitions involve selling your medical devices outside the United States, you’ll likely need to get ISO 13485 certified as well. We can help implement a fully integrated quality management system that complies with the FDA QSR and ISO 13485. Read more here.

We’re Ready to Help

If you're ready to take the next step in complying with FDA QMS requirements, our team is ready to help you get started.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

Get answers right now. Call
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