FDA 510k Submission & Compliance Consulting for Medical Device Software

Confidently Navigate FDA 510k Requirements

Ensure your medical device software meets all FDA 510(k) submission, clearance, and registration requirements.

QMLogic guides you through every stage of FDA compliance—from preparing technical documentation and managing cybersecurity risks to handling audits and regulatory correspondence.

Expert FDA 510k Submission Support

We guide your team through the FDA 510k submission process, offering comprehensive regulatory consulting to streamline your market entry in the U.S.

Preparation of complete 510k regulatory documentation and premarket notifications
Support with FDA registration requirements and device listing
Gap analysis and document readiness review for FDA 510k clearance
Alignment with FDA 510k cybersecurity expectations for connected devices

FDA Consultancy & Documentation Compliance (21 CFR 820.30)

Our consultants help you implement FDA Design Controls that align with 21 CFR 820.30 regulations:

Full support in establishing and maintaining Design History Files (DHF)
Verification & validation documentation per FDA standards
Integration of risk management aligned with ISO 14971 and FDA guidance
Documentation best practices that align with 510(k) expectations

Digital Compliance: 21 CFR Part 11 & FDA Cybersecurity

Modern software demands digital compliance. We ensure your systems meet all FDA cybersecurity and Part 11 electronic records standards:

Part 11 electronic records21 CFR Part 11 (e-signatures & digital records)
Cybersecurity integration into the development lifecycle for SaMD and connected devices
Preparation of cybersecurity documentation per FDA premarket guidance
Data integrity and access control policies that meet FDA 510(k) cybersecurity standards

FDA Medical Device Labeling & Registration

We help ensure your FDA medical device labeling requirements and registration obligations are fully met:

Support for FDA labeling requirements for medical devices
Guidance on U.S. agent requirements, device listing, and registration
Label compliance with UDI, intended use, and indications per FDA rules
Alignment with both physical and digital labeling expectations

Why Choose QMLogic as Your FDA 510k Consultants?

Proven Track Record
We have supported successful FDA 510(k) clearances and understand how to navigate complex U.S. regulations.
Practical Documentation & QMS Expertise
We integrate compliance into your actual processes—without creating unnecessary overhead.
FDA Cybersecurity Integration
We align development and security workflows to FDA expectations for modern connected devices.
Fast, Focused Regulatory Support
We simplify the FDA 510(k) submission process and prepare your team for audits and reviews with confidence.

Who Needs FDA 510k Submission & Compliance?

FDA compliance is mandatory for medical device manufacturers selling in the U.S., including:

SaMD (Software as a Medical Device) developers requiring 510k or De Novo submissions
Connected medical devices that collect, store, or transmit patient data
Mobile health applications used for diagnostics, monitoring, or therapeutic interventions