Secure. Compliant. Built to Last.
Custom Software Development for Software as a Medical Device (SaMD)
Partner with Art+Logic to develop FDA-aligned, HIPAA-compliant SaMD solutions—faster, safer, and with less regulatory risk.
The Path to SaMD Success Is Complex—But You Don’t Have to Navigate It Alone
SaMD projects require more than good code—they demand secure architecture, airtight documentation, and built-in compliance with FDA, ISO, and IEC standards.
We help medical device companies and healthcare innovators:
- Design and develop software that’s secure from the ground up
- Align with ISO 13485 and IEC 62304
- Build HIPAA-compliant platforms that scale
- Validate, document, and deploy with audit readiness in mind
- Avoid costly delays and post-launch risks
What We Deliver
Secure Software Development Lifecycle (SSDLC)
Regulatory guidance built into your roadmap
MVP-to-market development strategy
Modular, scalable, and future-ready architecture
Post-market support + long-term maintenance
interested?
Get Started with a Free Consultation.
Let’s Discuss Your Software Needs.
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Trusted by MedTech Innovators Like STAAR Surgical and Standard Clouds
With over 30 years of experience, Art+Logic combines technical excellence with deep regulatory awareness. We’re not just coders—we’re a strategic partner committed to your product’s success.
We bring:
- Decades of experience in regulated software environments
- Collaborative, transparent project management
- Long-term partnerships—not quick handoffs
- A deep bench of secure software developers, architects, and compliance-aware engineers
let’s talk