FDA 510(k) Submission & Compliance Consulting for Medical Device Software
What we offer
Comprehensive support for 510(k) submissions, including preparation of regulatory documentation and premarket notifications.
Implementation of 21 CFR 820.30 (Design Controls) to ensure your software development processes meet FDA requirements.
Guidance on compliance with 21 CFR Part 11 for electronic records and signatures, ensuring your digital systems are FDA-compliant.
Integration of cybersecurity measures into your product development lifecycle to meet FDA cybersecurity requirements.
Development and review of Technical Documentation and Design History Files (DHF) to align with FDA expectations.
Risk Management and validation practices aligned with FDA guidelines and integrated with ISO 14971 standards.
Practical training for your team on FDA requirements and best practices for submissions and audits.
Assistance in responding to FDA inquiries and managing regulatory correspondence.
Why Work With Us
Our team has extensive experience with U.S. regulatory submissions and understands the nuances of FDA requirements.
We have successfully supported multiple 510(k) submissions and other regulatory filings for medical devices.
We ensure that your design and documentation processes are efficient, practical, and aligned with FDA regulations.
Our experts are well-versed in aligning cybersecurity and software development practices with the FDA’s expectations for connected devices.
We simplify the complex FDA compliance process, ensuring that your team is confident and well-prepared for audits or reviews.
To whom does FDA Submission & Compliance apply?
FDA regulations, including 21 CFR 820.30, apply to all medical device manufacturers that plan to market their products in the United States. Specific scenarios include:
Software as a Medical Device (SaMD) manufacturers requiring 510(k) submissions or premarket approvals.
Developers of connected medical devices that process, store, or transmit patient data.
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