FDA 510(k) Software Requirements Specification (SRS) Template

FDA 510(k) Software Requirements Specification (SRS) Template

Are you preparing a 510(k) submission for your medical device software? Save time and ensure compliance with this professionally structured Software Requirements Specification (SRS) template, designed specifically to meet FDA expectations for medical device software documentation.

Created by an Experienced Medical Device Consultant

With years of hands-on experience in medical device software development and FDA 510(k) submissions, I’ve successfully led multiple full 510(k) applications from start to finish. This template is based on real-world regulatory experience, ensuring it aligns with FDA guidance, IEC 62304 software lifecycle processes, and industry best practices.

Why Choose This Template?

✅ 510(k) Submission Ready – Aligned with FDA guidance on software documentation.

✅ Pre-Formatted & Structured – Covers key SRS components, including functional requirements, risk management, and traceability.

✅ Customizable & Easy-to-Use – Adapt the template to your specific medical device software needs.

✅ Regulatory Best Practices – Developed with industry standards (IEC 62304, FDA guidance on software documentation) in mind.

✅ Created by an Expert with Hands-on 510(k) Experience – Benefit from real-world insights that streamline compliance.

✅ Reduces Submission Errors – Helps you provide clear, structured, and audit-ready documentation.

Who Is This For?

🔹 Medical device manufacturers preparing for FDA 510(k) submissions

🔹 Regulatory consultants and compliance professionals

🔹 Software engineers and developers working in medical device software

🔹 Startups and companies developing SaMD (Software as a Medical Device)

What’s Inside?

📄 Fully editable SRS template (.docx format)

📌 Pre-filled sections and expert guidance notes

📑 Clear structure for functional, performance, and risk-related requirements

Take the Guesswork Out of Your FDA 510(k) Submission!

Leverage my first-hand experience in FDA 510(k) submissions and simplify your documentation process with a submission-ready SRS template that meets regulatory expectations.

💡 Download Now and Get a Head Start on Your 510(k) Submission!