Medical Device Software Development (SaMD & FDA Compliance)

Build Software as a Medical Device (SaMD) with integrated FDA regulatory planning — from predicate research through submission support. IEC 62304, 21 CFR Part 11, and ISO 13485 built in from day one.

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Why SaMD Development Requires a Different Approach

Medical device software is not just software — it’s a regulated product. The FDA classifies SaMD based on the seriousness of the healthcare situation and the significance of the information provided. Getting classification wrong early in development can mean months of rework, delayed submissions, and missed market windows.

Taction approaches SaMD projects with regulatory strategy first. Before writing a single line of code, we determine FDA classification, identify the regulatory pathway, and design the development process to produce the documentation the FDA requires.

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Technology Stack

Every SaMD platform we build is powered by a carefully chosen technology stack designed for reliability, traceability, and FDA compliance. We combine proven cloud-native infrastructure with regulated software development tools that produce the documentation trail the FDA expects — design history files, risk analysis records, and verification/validation evidence — so your submission is ready when your product is.

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Rapid Development : Experience the TURBO

✔ Agile & User-Centric – Accelerated MVP development for faster market entry.
✔ Shortest Time-to-Market – Our TURBO framework ensures speed & efficiency.

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Frequently Asked Questions

Still evaluating how to approach your SaMD project with FDA compliance in mind? Below are the questions medtech founders and healthcare product leaders most often ask before engaging Taction on a medical device software initiative — covering classification, regulatory pathways, timelines, and development standards. If your question isn’t answered here, schedule a free consultation and our team will walk you through your specific scenario.

If your software is intended for a medical purpose (diagnosis, treatment, prevention, monitoring) without being part of a hardware device, it likely qualifies as SaMD. Classification depends on the clinical situation and information significance.

We prepare the documentation the FDA requires (design history file, risk management file, verification/validation evidence) and support your regulatory consultants or internal team through the submission process.

510(k) is used when your device is substantially equivalent to an existing predicate. De Novo is for novel low-to-moderate risk devices with no predicate. PMA is required for Class III high-risk devices.

If your CDS tool presents recommendations with supporting evidence that clinicians can independently evaluate, it may qualify as non-device — exempt from FDA review. We help you determine whether your tool fits the exemption criteria.