Vision
To bridge the gap between innovative software development and rigorous medical compliance. We believe that regulatory requirements shouldn’t slow down innovation—they should provide the framework for excellence.
Our Story
Syntax Regulatory was founded at the intersection of two worlds: the fast-paced, iterative world of software engineering and the highly structured, safety-critical world of medical device regulations.
Our name, Syntax, reflects our core philosophy. In programming, syntax is the set of rules that defines a correctly structured program. In the medical world, Regulatory Design Control is the syntax of safety. Without it, even the most brilliant software cannot reach the patients who need it.
We saw too many ground-breaking SaMD (Software as a Medical Device) projects stall due to "regulatory friction." We built this consultancy to provide the missing link—translating complex FDA and ISO 13485 requirements into actionable, developer-friendly workflows.
What We Do
We specialize in Design Controls for Medical Software. We don't just tell you what the regulations are; we help you build the "objective evidence" required to prove your software is safe and effective.
- Design History File (DHF) Construction: We guide the documentation of your entire development journey.
- Traceability Logic: We help map User Needs to Design Inputs, Outputs, and ultimately to Verification and Validation.
- Risk Management (ISO 14971): Integrating software failure mode analysis into your design process.
- Audit Readiness: Moving you from "coding" to "compliant" with a system that stands up to FDA and Notified Body scrutiny.
Why Choose Us?
- Software-First Perspective: Most regulatory consultants come from hardware. We speak Git, Agile, and CI/CD. We know how to apply 21 CFR Part 820 to a modern software stack.
- Precision & Structure: Like the code we help protect, our processes are logical, repeatable, and robust.
- Patient-Centric Rigor: We never lose sight of the end goal: ensuring that digital health solutions are safe for the people who rely on them.
- Free resources: SaMD specific SOPs, WIs, Guidance, Excel
Our Core Values
- Integrity in Data: We believe "if it isn't documented, it didn't happen." We prioritize absolute accuracy in verification and validation.
- Agile Compliance: We advocate for "Continuous Compliance"—integrating design controls into your daily development rather than treating them as a final hurdle.
- Clarity over Complexity: Regulatory language can be dense. We translate it into clear, executable technical requirements.
Ready to define your regulatory syntax? please check how we work page for syntax way of working on SaMD Programs.