SaMD Technology &Engineering Support Services
Scale SaMD products faster with expert engineers, secure integrations, and compliance-ready design.
Bridging Technology Gaps for SaMD Innovators
Building and scaling Software as a Medical Device (SaMD) products requires far more than great clinical insight. Teams often run into technology capability gaps, integration complexity, regulatory pressure, and cybersecurity demands, all while moving fast in competitive markets.
At Ekipa.ai, we partner with SaMD companies to close critical technology gaps, accelerate development, and support compliance efforts in a practical way. Our goal is to strengthen your capabilities without disrupting your core team or slowing down your roadmap.
How We Support SaMD Companies
1. Technology Gap Assessment & On-Demand Engineering Resources
SaMD product teams frequently need specialized technical expertise at different stages of development. We help you scale precisely where needed.
What we do:
Assess your current product architecture and technical capabilities
Identify gaps in AI, backend, frontend, cloud, data, or interoperability layers
Provide dedicated engineers or cross-functional teams aligned to your tech stack
Scale resources up or down based on your product lifecycle
Result: Faster execution without long-term hiring risk.
2. Modular SaMD Product Development
Whether you’re building a new capability or enhancing an existing product, we support module-based development as an extension of your internal team.
We help you develop:
AI/ML diagnostic or decision-support modules
Data ingestion and processing pipelines
Patient monitoring or analytics modules
Clinician dashboards and reporting layers
Interoperability and workflow automation components
We follow SaMD-aligned development practices with documentation, traceability, and validation readiness built in from day one.
3. EHR & Healthcare System Integrations
Interoperability is critical for SaMD adoption and clinical usability. We support seamless integration with healthcare systems and data standards.
Our integration expertise includes:
EHR/EMR integrations
HL7, FHIR, and API-based interoperability
Secure data exchange and workflow integration
Third-party healthcare platforms and devices
We already offer specialized implementation services, and this SaMD support builds on that foundation.
4. Regulatory & Compliance Enablement for SaMD
Regulatory readiness is often a major bottleneck for SaMD companies. We provide technology-focused compliance support that complements your regulatory strategy.
We support technology compliance for:
EU MDR / IVDR (software classification, technical documentation readiness)
FDA (SaMD & Digital Health) development alignment
Secure software lifecycle processes
Audit-ready system architecture and documentation
This means your product is designed with compliance in mind from day one, rather than scrambling to adapt it later.
5. Cybersecurity & Data Protection for SaMD Products
Cybersecurity is a non-negotiable requirement for SaMD solutions handling sensitive health data. Our SaMD services align closely with our dedicated cybersecurity practice.
Security capabilities include:
Secure software architecture design
Data privacy and protection best practices
Threat modeling and risk mitigation
Compliance with healthcare cybersecurity standards
Our cybersecurity expertise extends beyond SaMD, supporting secure digital health ecosystems across the product lifecycle.
Why SaMD Companies Choose Ekipa.ai
Proven experience in healthcare and regulated software development
Flexible engagement models (resources, modules, or full teams)
Strong integration and interoperability expertise
Compliance-aware engineering practices
Ability to scale with your product: from MVP to market expansion
"We don’t step in to take over. We plug in where you need us and make your team stronger."
Frequently Asked Questions
We work with early-stage startups, scale-ups, and established healthcare technology companies building Software as a Medical Device solutions. Our support spans MVP development, product enhancement, interoperability, and compliance-ready scaling.
Let’s Accelerate Your SaMD Product
Whether you need specialized engineers, a development partner for a specific module, EHR integrations, or compliance-ready architecture, Ekipa.ai supports SaMD innovators at every stage.