Your medtech partner who truly understands software, compliance, and security.
Focused exclusively on regulated medical device software, wireless, and embedded systems with proven regulatory fluency and world-class cybersecurity expertise.
What Sets Us Apart
Why medtech startups choose Bold Type for their mission-critical software development
Focused exclusively on regulated medical device software
We don't build generic software. Our entire practice is dedicated to medical device software, wireless, and embedded systems. We speak the language of IEC 62304, ISO 14971, and FDA guidance documents.
Proven regulatory fluency: Pre-market to post-market readiness
Our team has navigated dozens of FDA submissions. We create documentation that reviewers understand and approve, aligned with the latest FDA guidance on cybersecurity and software lifecycle processes.
CyberMed division houses world-class cybersecurity experts
Led by NSA/DoD veterans with mission-critical and FIPS-grade experience, our CyberMed division provides threat modeling, penetration testing, and post-market cybersecurity management.
AI-powered workflows inject speed without compromising technical rigor
Our AI coding agents accelerate routine development safely—not for "vibe coding", but to deliver audit-ready quality faster than traditional methods while maintaining full compliance standards.
Our Ideal Clients
Founders and leaders under pressure to deliver compliant, investor-ready outcomes
You're building groundbreaking medical technology that could save lives and transform healthcare. But you're also facing tight timelines, limited budgets, and the complexity of FDA regulations. You need a partner who understands the stakes and can deliver software that meets the highest standards for quality, security, and compliance.
You might be:
- • A medtech startup preparing for Series A funding with a working prototype
- • A medical device company navigating their first FDA submission
- • An established company expanding into connected/digital health solutions
- • A team that needs cybersecurity expertise for FDA compliance
Why This Expertise Matters
Generic software developers don't understand medical device complexity
Building software for medical devices isn't like building a consumer app. It requires understanding of risk management, validation protocols, and regulatory requirements that most developers have never encountered.
Compliance gaps can derail your timeline and funding
One missing document or security vulnerability can set back your 510(k) submission by months and jeopardize your next funding round. We ensure nothing falls through the cracks.
Cybersecurity is now a regulatory requirement, not optional
The FDA's updated cybersecurity guidance makes security documentation mandatory for most submissions. Our CyberMed experts help you navigate these requirements with confidence.
Speed to market is critical in medtech
Every month of delay costs you market opportunity and investor confidence. Our proven frameworks and AI-assisted development help you ship faster without cutting corners.
Ready to work with a partner who truly gets medtech?
Let's discuss how we can help you build software that's secure, compliant, and investor-ready.