For MedTech Engineers
Medical device software is judged by more than whether it runs. Reviewers want to see the requirements, architecture, risk analysis, and testing behind it, and a process that matches the software's safety class. Concise Engineering helps teams developing embedded and cloud-based software build IEC 62304 compliant processes and documentation in from the start, so compliance supports the work instead of slowing it down.
Sound Familiar?
- We write good code, but our documentation doesn't show how we got there.
- I'm not sure which IEC 62304 software safety class applies to us.
- Requirements live in tickets and chat threads, and traceability is a mess.
- We rely on third-party and open-source components and don't know how to document them.
Software Development With the Evidence Built In
IEC 62304 doesn't tell you how to code. It defines the lifecycle activities around your code... planning, requirements, architecture, risk management, verification, and maintenance... scaled to the software's safety class. We develop software architecture, requirements, code, and testing for embedded and cloud-based platforms, with quality oversight on both process and execution, so your software file grows with the product.
- Software architecture and requirements for embedded or cloud-based platforms
- Software safety classification and an IEC 62304 lifecycle sized to it
- Traceability from requirements through code, tests, and risk controls
- Software quality oversight on process and execution
Why Concise Engineering
- Engineers talking to engineers. We fit compliance into how your developers already work, not a process that buries them in paperwork.
- Risk first. We tie software requirements to risk analysis, so testing effort goes where a failure could cause harm.
- Access, not just engineering. With systems, electrical, and regulatory expertise on the same team, software decisions account for the whole device.
How It Works
- Discovery call - your device, your software, and where the process stands
- Software safety classification and gap assessment
- Lifecycle, architecture, and traceability setup
- Development and verification support through submission
Frequently Asked Questions
What is IEC 62304?
IEC 62304 is the international standard for the medical device software lifecycle. It covers planning, requirements, architecture, design, implementation, verification, risk management, configuration management, and maintenance. FDA recognizes it as a consensus standard, so following it is a common way to show your software process is sound.
What are the IEC 62304 software safety classes?
Software is classified A, B, or C based on the harm that could result if it fails. Class A means no injury is possible, Class B means non-serious injury is possible, and Class C means death or serious injury is possible. The higher the class, the more documentation and testing the standard requires.
Does IEC 62304 apply to cloud-based software?
It applies to software that is a medical device or part of one, wherever it runs. Embedded firmware, mobile apps, and cloud services can all fall in scope if they affect the device's safety or performance. Intended use decides, so settle early which parts of your system are in scope.
How do we handle third-party and open-source software?
IEC 62304 calls these SOUP, software of unknown provenance. You don't have to rebuild them, but you do need to identify each one, define the requirements it must meet, review known issues, and account for its risks. A SOUP list kept current with each release saves a scramble before submission.
What does FDA expect to see for device software?
FDA's guidance on premarket submissions for device software functions describes what to include, at a Basic or Enhanced documentation level based on risk. It typically covers a software description, risk management, requirements, architecture, testing, and version history. Building to IEC 62304 makes that package much easier to assemble.
Build the software and the evidence together. Let's set up a process your team can actually work with.
Book a Discovery Call
Concise Engineering helps medical device teams develop embedded and cloud-based software under an IEC 62304 lifecycle, including safety classification, architecture and requirements, traceability, SOUP management, and software quality oversight for FDA submission.