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
.png)
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.