21 CFR Part 820 Consulting for Medical Device Companies
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.
From theory to reality, FDA QSR systems made understandable and usable.
Our 21 CFR Part 820 Consulting & Implementation Services
Build & Align Your QMS
Set the foundation for compliance and growth with a scalable, audit-ready QMS.
QMS Implementation & Process Design
Practical, efficient systems tailored to FDA QSR and ISO standards.
ISO 13485 & 21 CFR 820 Harmonization
Practical, efficient systems tailored to FDA QSR and ISO standards.
Turnkey Technical Documentation
Full support for documentation under IEC 62304, ISO 14971, and more.
Design Controls & Development Support
Bring your product to market with compliant, traceable, and modern design systems.
FDA 820.30 Design Controls Consulting
Full lifecycle support from planning through verification and validation.
Design Documentation Setup
Includes traceability, architecture, and integration with IEC 62304 & AI/ML workflows.
FDA 820.30 Software Tools
Custom tools for eQMS, automated design control and technical file creation.
Audit Readiness & Inspection Support
Stay inspection-ready with tailored audit support at every level.
Internal Audits & Gap Analysis (820.22)
Conducted by certified experts aligned with FDA and ISO 13485.
External Audit Support
Full prep and on-site or remote support for FDA, Notified Bodies, or client inspections.
Customer/Supplier Audits
Third-party audits to qualify or monitor your partners.
Digital QMS & Automation
Accelerate compliance and eliminate manual bottlenecks with modern, digital tools.
Document Control & eQMS Setup (820.40)
SharePoint, Confluence, or custom systems with role-based access and versioning.
CAPA System (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.
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.
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.
One system, full compliance. FDA, ISO 13485, EU MDR, all under control.
- Delivery of QMS systems certified under ISO 13485Management of technical documentation per IEC 62304Risk management systems aligned with ISO 14971510(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.
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.
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
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.
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.
Learn more about our QMS digitalization and automation
Related Regulations We Support
FDA compliance beyond 21 CFR 820
21 CFR Part 860
Medical Device Classification
IEC 62366
Application of Usability Engineering to Medical Devices
ISO 13485
Medical Device Compliance
ISO 14971
Managing Risks Effectively
IEC 62304
Guiding the Software Lifecycle
21 CFR Part 814 & 807
Premarket Approval / 510(k)
EU MDR 2017/745
European Medical Device Regulation
IEC 81001-5-1
Addressing Cybersecurity Risks
ISO 42001 (AI)
Artificial Intelligence Management System
Testimonials | Our Expertise in MedTech
Merck Group
Risk Manager
I had the pleasure to work with Vaclav during our development of a medical product for Merck. I found Vaclav to be very professional and devoted. His attention to detail and his technical /medical knowledge brought immense valuable inputs to the project. Collaborate with Vaclav was really a pleasure and I warmly recommend him.
Dentsply Sirona
Chapter Lead and Manager Scrum Masters
I had the pleasure to work with Vaclav on Software as Medical Device processes topics, and can only recommend him! It is not only that he has a very high and reliable knowledge in the medical domain, the regulatory domain and the software one, but also that whatever he approaches, he does it in a reasonable and clever way, taking into account the big picture and the real expectations from authorities and the goals of the organisation. With a good internal sponsor to support him, he delivers on his promises very efficiently, and collaborates in a great way, relying on his very good communication skills!
Connected Services
Regulatory Consulting for SaMD
Ensure complete MDR, FDA, IEC 62304, ISO 14971, and cybersecurity compliance.
We understand the regulatory environment. We have experience in implementing all standards related to medical software development, cybersecurity, and technical documentation, and we would be happy to demonstrate in practice how we can translate this expertise into real-world solutions while working on your medical device software product - as a developers a project managers.
- Real-World Solution for Your Organization
QMS Digitalization & Automation
Implement ISO 13485-compliant processes using Jira, Confluence, and SharePoint.
At QMLogic, we empower organizations to revolutionize their Quality Management Systems (QMS) with cutting-edge automation tools. Our expertise spans Microsoft SharePoint, Power Platform, Confluence, Jira, and custom-built solutions tailored to specific needs.
- Future of Quality Management
