Your software works. Your Design History File either doesn't exist yet or lives in a folder nobody wants to open before the submission. We write the IEC 62304 documentation and set up the quality system, and your engineers keep shipping.
A software Design History File (DHF) is the documented record of how a medical device's software was planned, specified, designed, built, verified, and released. FDA expects it to follow IEC 62304 software life cycle processes and to trace requirements through design and testing. CyberMed writes the software DHF, sets up the supporting SOPs, and aligns it with the cybersecurity documentation the same submission needs.
By Jose Bohorquez, PhD, President · Updated
On the call you'll hear what's missing from your software documentation, whether or not we do the work.
Your development team ships fast and solves hard problems, but FDA reviewers don't care how clever your code is. They care whether you can prove it works and that you followed the process. If your software requirements spec is incomplete, your traceability matrix has gaps, or your verification protocols don't map to your risk analysis, your submission stalls.
Most startups learn this the hard way: months into a 510(k) review, scrambling to reverse-engineer documentation they should have built from day one.
First-time submitters often discover IEC 62304 and design control requirements after their software is already built, forcing expensive rework.
Software engineers aren’t trained in regulatory documentation. Asking them to write an SRS or SVP from scratch wastes their time and produces documents that don’t pass review.
Regulatory affairs knows what FDA expects, but software documentation requires someone who understands the code. That’s a different skill set, and most teams don’t have it in-house.
We work alongside your engineering team to build every document FDA expects to see, structured to IEC 62304 and mapped to your actual development workflow.
Software documentation for FDA sits in a gap between engineering and regulatory affairs. Your RA team knows the submission process. Your engineers know the code. But writing an SRS, building a traceability matrix, or documenting a software architecture in a way that satisfies IEC 62304? That takes someone who lives in both worlds. That's where we come in.
We work directly with your developers to document what they’ve actually built. The result is documentation that your RA team and FDA reviewers can trust because it reflects reality.
You’re moving fast with a lean team. Our process fits into your sprint cadence. Not the other way around.
Need cybersecurity documentation too? Most of our clients do. We deliver both DHF and cybersecurity packages as one coordinated program, saving time and cutting redundant work.
If your device connects to a network, stores patient data, or runs as SaMD, FDA requires a complete cybersecurity package alongside your software DHF. We're one of the few firms that deliver both as a single engagement.
See our CyberSprint™ Program →We'll review your current software documentation, tell you what's missing, and give you a clear picture of what it takes to get FDA-ready. No obligation.
4 to 8 weeks depending on software complexity and how much documentation you already have. Starting from scratch takes closer to 8.
No. We work alongside your dev team during active sprints. It’s actually better if development continues since we can document in real time instead of reverse-engineering.
That’s what the gap analysis is for. We review what you have, find the holes, and map out the fastest path to a complete DHF.
Yes. It’s our core business. Most clients hire us for both software DHF and cybersecurity as a bundled program.
We work within IEC 62304 (software lifecycle), ISO 14971 (risk management), IEC 81001-5-1 (cybersecurity), and FDA’s premarket software documentation guidance. We coordinate with your regulatory team to make sure everything aligns with your broader submission strategy.
No. We handle the software-specific technical documentation that sits between engineering and regulatory. Your RA team or consultant owns the submission strategy and the broader regulatory package. We make their job easier by giving them clean, complete software documentation they can plug right in.