21 CFR Part 820 Consulting Services
FDA Quality System Regulation (QSR) Experts You Can Rely On
Struggling with Title 21 CFR QMSR compliance? You're not alone — and you're not without help. At QMlogic, we specialize in practical implementation of FDA Quality System Regulation (21 CFR Part 820) with full alignment to ISO 13485, CGMP, and EU MDR frameworks.
We don’t just hand you a template, we work with you to build a system that’s audit-ready, scalable, and truly understood by your team.
“We don’t just do gap analysis. We also tell you what you don’t need to do.”
“From theory to reality—FDA QSR systems made understandable and usable.”
Our 21 CFR Part 820 Consulting Services
1. Build & Align Your QMS
Set the foundation for compliance and growth with a scalable, audit-ready QMS. Regulatory Affairs Consulting Services:
- QMS Implementation & Process DesignPractical, efficient systems tailored to FDA QSR and ISO standards.
- ISO 13485 & 21 CFR 820 HarmonizationOne system, multiple regulations — aligned for global compliance.
- Turnkey Technical DocumentationFull support for documentation under IEC 62304, ISO 14971, and more.
2. Design Controls & Development Support
Bring your product to market with compliant, traceable, and modern design systems. Medical Software Development:
- FDA 820.30 Design Controls ConsultingFull lifecycle support from planning through verification and validation.
- Design Documentation SetupIncludes traceability, architecture, and integration with IEC 62304 & AI/ML workflows.
- FDA 820.30 Software ToolsCustom tools for eQMS, automated design control and technical file creation.
3. Audit Readiness & Inspection Support
Stay inspection-ready with tailored audit support at every level. Capa services:
- Internal Audits & Gap Analysis (820.22)Conducted by certified experts aligned with FDA and ISO 13485.
- External Audit SupportFull prep and on-site or remote support for FDA, Notified Bodies, or client inspections.
- Customer/Supplier AuditsThird-party audits to qualify or monitor your partners.
4. Digital QMS & Automation
Accelerate compliance and eliminate manual bottlenecks with modern, digital tools. QMS Automation & Digitalization:
- Document Control & eQMS Setup (820.40)SharePoint, Confluence, or custom systems with role-based access and versioning.
- Corrective & Preventive Action (CAPA) Systems (820.100)Lean, user-friendly frameworks integrated into your QMS platform.
- Digital Records & CFR Part 11 Compliance (820.180)Secure, automated systems with audit trails and e-signatures.
Why Choose QMLogic for 21 CFR 820 Compliance & QMSR Implementation
Audit-Proven Results
We’ve successfully supported clients through FDA inspections, MDSAP audits, and EU MDR Notified Body assessments. Our consultants know what regulators expect, and how to deliver systems that pass the audits.
ISO & FDA Harmonization Experts
Our team specializes in aligning ISO 13485 and FDA 21 CFR 820 requirements, creating unified quality systems that satisfy global regulations without duplication or confusion.
Practical, Real-World Approach
We design lean, scalable QMS systems that make sense in real operations, not just on paper. Whether you are a startup or scaling manufacturer, our approach fits your pace and your product.
Tech-Enabled Compliance
We build modern QMS platforms using SharePoint, Power Platform, Jira, Confluence, or custom software. Our digital systems are automation-ready, CFR Part 11-compliant, and tailored to the strict MedTech requirements.
Learn more about our QMS digitalization services
21 CFR 820 & ISO 13485 Harmonization
Aligning Global Standards for Streamlined Compliance
With the FDA’s Quality Management System Regulation (QMSR) final rule, 21 CFR 820 is being aligned with ISO 13485. This means compliance strategies work across regulatory systems, not just one.
Our team has:
- Delivered QMS systems certified under ISO 13485
- Managed technical documentation per IEC 62304
- Built risk management systems aligned with ISO 14971
- Navigated successful 510(k) submissions aligned with 21 CFR 820 requirements
We’re the perfect partner to bridge the gap between ISO and FDA expectations, ensuring global compliance from a single source of truth.
“One Quality System. Global Compliance.”
Full Compliance with All Parts of Title 21 CFR Part 820
End-to-End Support for FDA Quality System Regulation (QSR / QMSR)
At QMLogic, we support complete implementation of Title 21 CFR Part 820, guiding medical device companies through every subpart of the FDA’s Quality System Regulation, from general provisions to statistical techniques.
Whether you're launching a new device or remediating an existing QMS, we provide expert consulting, practical tools, and technical execution for full FDA and ISO alignment.
Digitalization & Automation for Faster, Smarter Compliance
At QMLogic, we don't just interpret the regulation, we accelerate it.
We design and deliver automated, digital solutions that speed up the implementation of your FDA-compliant Quality Management System, reduce manual effort, and enhance traceability.
- Custom QMS software that supports any subpart of 21 CFR Part 820
- SharePoint and Power Platform solutions for document control, CAPA, design control, and more
- Software tools to digitize processes with built-in compliance checks
- Real-time dashboards, automated recordkeeping, and integration with e-signature systems
- AI-enhanced workflows for risk management, audits, and design reviews
Every QSR requirement, from 820.30 Design Controls to 820.100 CAPA, can be supported with digital tools to accelerate delivery, reduce risk, and maintain continuous inspection readiness.
Focused Expertise on Critical 21 CFR Part 820 Subparts
🔍 820.22 – Quality Audits
Internal, External & Customer Audit Services
We offer flexible, expert-led audit services tailored to FDA QSR, ISO 13485, and EU MDR:
- Internal audits tailored to FDA and ISO 13485
- Full audit preparation & readiness checks
- External audit support for FDA, CFR Notified Bodies, and Client Audits
- Actionable gap analysis that cuts overhead, not just identifies it
📐 820.30 – Design Controls
Structured, Multi-Standard Design Control Systems
We help companies implement FDA 820.30-compliant Design Control systems that also align with essential global standards:
- Complete design & development documentation setup
- Seamless integration with:
- Support for modern architectures (cloud, OTS software, AI/ML, cybersecurity)
“Design Control is not just a checklist. It’s the heart of innovation done right.”
📄 820.40 – Document Controls
Modern Document Systems for Compliant Knowledge Flow
- Setup of easy-to-use digital document control systems
- SharePoint, Jira, Confluence, and custom workflows with AI assist
- Procedures that ensure information is controlled, accessible, and audit-ready
🔄 820.100 – Corrective & Preventive Action (CAPA)
CAPA Systems That Drive Improvement — Not Bureaucracy
- Lean and understandable CAPA frameworks
- Built-in tools, escalation paths, and corrective action tracking
- Root cause analysis tools integrated with your QMS
- Clear roles, timelines, and ownership to make CAPA work for people, not against them
🗃️ 820.180 – Records & CFR Part 11 Compliance
Smart, Automated, and Fully CFR Part 11-Compliant Record Systems
- Digital record strategies tied to approval workflows
- Integrated electronic signature systems
- Records auto-generated from processes wherever possible
- Focused on accessibility, compliance, and efficiency
Related Regulations We Support
FDA compliance beyond 21 CFR 820
- 21 CFR Part 11 – Electronic Records and Electronic Signatures
- 21 CFR Part 860 – Medical Device Classification
- IEC 62366 – Application of Usability Engineering to Medical Devices
Ready to Build a Compliant, Scalable Quality System?
We bring practicality, clarity, and confidence to regulatory compliance. If you're facing the complexity of 21 CFR Part 820, we’re here to simplify it.
- ✅ “We make your quality system work for you—not the other way around.”
- ✅ “One system, full compliance. FDA, ISO 13485, EU MDR—all under control.”