Let Our QMS Team Answer These Key Questions for You…
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How do we get started implementing a QMS?
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Can we implement a new QMS in stages?
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How long will it take and what resources will be required?
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Do we need to comply if we outsource all manufacturing?
Our Staged Approach to FDA QMS Compliance
You can read the entire FDA QMSR (21 CFR 820) in less than half an hour but – unless you have someone who knows how to interpret FDA’s supplemental requirements and its integration with ISO 13485 – 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 framework, including the incorporation by reference to ISO 13485. 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 Management System Regulation (QMSR), 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 ISO 13485 clauses and FDA Supplemental Provisions (those requirements that go beyond ISO 13485), 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 ELIQUENT Medical Device QMS Implementation Process
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FDA Quality Management System Regulation (21 CFR Part 820) Structure
Subpart A: General Provisions
Subpart B: Supplemental Provisions
Incorporation by Reference: Reference to ISO 13485
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 QMSR 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.