Is this you?
Founder or CTO of a MedTech or SaMD startup
aiming for market authorization?
VP of Product or Director of R&D at a growing MedTech enterprise struggling to integrate AI safely and compliantly?
Regulatory lead needing better collaboration across engineering, data, and quality teams?
WELCOME
We engineer what's next in MedTech.
We build safe and effective medical devices that align with regulatory expectations, clinician requirements, and the needs of the target patient population – ensuring seamless workflow integration, improved process efficiency, and better patient outcomes.
IN PARTNERSHIP WITH
One Team.
Purpose-built systems.
Regulatory-forward design.
We help MedTech startups and enterprises bring transformative devices and Software as a Medical Device (SaMD) solutions to market – faster, safer, and in full regulatory and commercial alignment. Our synergy and shared mission fuses us into one team, and our diverse experiences contribute to a whole greater than the sum of its parts.
We are known for our precision, depth, and client empathy. We work across public-private sector, human-centered medical device development, and clinical experts to design solutions that perform and have proven usability and adoption in clinical settings and across stakeholders.
Book a Strategy Call
Our promise to MedTech leaders.
If you're building AI-enabled diagnostics, connected devices, or enterprise-grade platforms in the U.S. healthcare market, you know the stakes.
We reduce regulatory risk, accelerate time-to-approval, and scale your engineering capability – without compromising innovation.
We are a team built for MedTech
Engineered for Clearance.
Compliance from Day One
Every system we build is mapped to the relevant FDA, ISO 13485/14971, IEC 62304/60601/62366, and HIPAA frameworks. We design according to the specific regulatory pathway you pursue (e.g. FDA 510(k), De Novo, CE Marking).
Full-Stack Systems & AI Engineering
From machine learning (ML), natural language processing (NLP) models, and privacy-preserving AI (e.g. encrypted inference, protected execution environments) to embedded firmware and electrical systems – we lead full-stack engineering and system architecture.
Strategic Regulatory Integration
We align engineering and regulatory teams through structured documentation, DHF development, QMS implementation, and FDA submission support. Eliomedica's medical device innovation and regulatory affairs expertise boosts DigiDaaS' breadth and depth.
Sovereign AI Infrastructure
Secure, auditable, and jurisdiction-aware. With Whole AI Foundry™, our AI, data, and cloud experts design for traceability, explainability, dynamic risk, and long-term resilience. We spend focused time understanding your priorities and architect effective, aligned solutions which account for the relevant ISO/IEC 42001/23894, EU AI Act and AI regulation.
Market-Ready by Design
Beyond compliance, we bring go-to-market clarity – with product strategy, messaging, brand architecture, and ecosystem partnerships built into the development lifecycle. From positioning and modern PR to digital presence and investor visibility, we ensure your MedTech solution launches with clinical, regulatory, and commercial alignment.
Book a Compliance Readiness Call
You’ve come to the right place.
Our Capabilities.
Let’s create something awesome together.
We have different engagement options.
Strategic Advisory & Positioning
Strategic Advisory & Positioning
- •AI readiness assessments, regulatory roadmap development, and compliance strategy
- •Product-market fit, go-to-market planning, and clinical/regulatory alignment
- •Brand architecture, investor narrative development, and PR positioning
Implementation & Training
Implementation & Training
- •Fractional CTO, CAIO, CPO, and regulatory/QA leads and enablement strategies
- •Embedded cross-functional teams for AI, engineering, regulatory, and go-to-market
- •Continuous support across the product, compliance, and commercial lifecycle
End-to-End Build & Launch
End-to-End Build & Launch
- •Full-cycle delivery from concept through FDA clearance and market entry
- •Audit-ready AI systems: compliance, validation, and documentation aligned with FDA and EU AI Act.
- •Post-market surveillance, performance monitoring, and investor-grade visibility assets
Case Studies.
From strategy development to execution, see the transformative impact we've delivered across diverse industries.
Pioneering Cannabis Impairment Detection
After a failed AI partnership, Gaize, Inc. turned to DigiDaaS to solve one of the most complex challenges in safety tech: accurately detecting cannabis impairment. Through deep scientific exploration and custom machine learning models, DigiDaaS delivered the worlds first reliable cannabis impairment detection solution—unlocking new market opportunities and positioning Gaize as a leader in impairment technology.
Compliance-Ready Efficiency Unlocked
As VISIE prepared for FDA compliance, they needed a roadmap to align with standards like ISO 13485 and IEC 62304. DigiDaaS delivered a comprehensive compliance strategy and phased implementation plan, while introducing CI/CD, build automation, and operational streamlining. The solution not only positioned VISIE for regulatory success—it also projected savings of $5,000/month per engineer by eliminating inefficiencies and accelerating development workflows.
AI-Powered Document Intelligence
We transformed healthcare and legal operations by automating document processing with AI, RAG, and vector databases. The solution cut processing time by 94%, reduced errors by 83%, and delivered $1.2M in annual savings, all while improving compliance and accelerating patient care and contract management.
Let's get you FDA-ready.
Whether you're preparing a Q-submission, building your MVP, or scaling post-approval – we align product, data, and compliance to get you to market faster.
Ready to accelerate your path to FDA clearance?
Let's map your regulatory trajectory, product roadmap, and AI stack – together.
Start Your FDA-Readiness Journey Today
Meet your MedTech Leaders
DigiDaaS is more than a company – it’s a community of world-class talent driven by passion, precision, and purpose. We’re not just solving problems; we’re building a future where engineering is fun, people come first, and every challenge is an opportunity to create something incredible.
At DigiDaaS, we don’t just build solutions – we build teams, tackle real-world challenges, and shape the future of engineering.
