Embedded & Connected Device Integration
Embedded software and connectivity engineers specializing in BLE, NFC, Wi-Fi, and cellular integration for biosensors, wearables, and connected medical devices.
MEDTECH SOFTWARE DEVELOPMENT STAFF AUGMENTATION
Software Development Staff Augmentation for MedTech and Digital Health
We help MedTech and Digital Health companies accelerate their development by providing highly skilled talent on demand. Our staff augmentation services reduce the complexity of hiring, mitigate project risks, and enable faster time-to-market—all while maintaining the highest standards.
Why Choose Sequenex?
Our engineers operate within the documentation, validation, and quality system discipline that medical device software requires, so they contribute from day one rather than spending months learning the regulated environment.
Seamless Integration
Our augmented staff and dedicated teams align with your workflows and project goals.
Consulting Expertise
We can manage the entire software product development lifecycle – from concept through commercialization.
Industry-Specific Expertise
Specialized knowledge in Medtech and Digital Health software development with a focus on biosensors, CGM, wearables and connected devices.
Faster Time-to-Market
Sequenex resources contribute from day one, reducing hiring delays and accelerating project delivery.
Biowearable and BLE experts
We are experts in biowearable technology and BLE, delivering reliable, energy-efficient solutions for seamless connectivity.
Regulatory-Ready Processes
Compliance with FDA, HIPAA, ISO 13485, IEC 62304, ISO 14971 and SOC 2 readiness built into every project.
Engagement Flexibility
Adapt team size and skill sets as your project needs evolve, with month-to-month flexibility through fixed-term arrangements and no long-term commitment required.
Diabetes Software Product SMEs
Engineers with subject matter expertise in CGM and CGM software, the diabetes care category where our team holds its deepest domain knowledge.
Staff Augmentation Engagement Models
Staff Augmentation
What is It
Specialized software staff augmentation: engineers placed into your existing team under your engineering direction, on an hourly or monthly contract, onboarded through Sequenex’s SaMD-Trained Engineer program before assignment.
Ideal For
- Filling specialized capability gaps you can’t hire fast enough to cover
- Expanding development bandwidth for a defined project ramp
- Adding regulatory-fluent engineers for IEC 62304 or ISO 13485 work
- Multi-quarter execution without permanent headcount commitment
Key Benefits
Engineers ready to contribute to regulated software work, with the documentation discipline already in place
Engagement length matched to your project, not to vendor preference
The difference between an anonymous marketplace and a specialized staff augmentation firm
Rent Your Own Dev Team by Subscription
What It Is
A monthly subscription that gives you a dedicated software development team: engineers, QA, DevOps, and a project manager, managed by Sequenex but working under your direction on your codebase and your roadmap.
Who it’s for
Mid-size medical device and digital health companies running a sustained engineering program, typically six months to multi-year, who want a dedicated development team without the management overhead of pure staff augmentation.
Core promise
Day-one productivity from a team trained in regulated software discipline, with the flexibility to scale up or down at the end of any billing cycle.
Key Benefits
A fully managed cross-functional team tailored to your project needs. Best for:
Predictable Budgeting
One plan, one price—no scope creep or surprise invoices.
Rapid Staffing
We handle recruiting, onboarding, and coverage so your program is productive from day one
Scalable Capacity
Flex team size at the end of any billing cycle
Engineering Under ISO 13485-Certified QMS
Traceability, documentation, and quality discipline aligned to your regulatory team's work
A Named Team, Not a Marketplace
Engineers who learn your codebase, standards, and domain, and stay with the program
Specialist Engineering Capabilities, Available On Demand
Across hourly, monthly, and dedicated-team engagements, the engineers placed through Sequenex contribute across five capability areas, each fluent in the regulatory frameworks medical device software requires.
Mobile & Cloud Engineering
Native iOS, native Android, and cloud engineers familiar with the regulated medical device software environment.Cloud & Edge Infrastructure
HIPAA-ready cloud architecture and edge computing engineers, working in your AWS environment under your operational control.
AI/ML Engineering
AI and machine learning engineers with reproducible pipeline practices, version control discipline, and familiarity with FDA AI/ML guidance for regulated software.Automated Testing & Continuous Delivery
Test engineering and DevOps specialists who can implement continuous delivery and continuous compliance practices inside your engineering organization.
Engineers Trained on Medical Device Software Discipline Before Assignment
Medical device software lives in a regulatory environment most software engineers have never encountered. Engineers from generic IT staff augmentation firms can write code, but the first months of their engagement are typically spent learning what design history files are, what software safety classifications change, and why documentation discipline matters as much as implementation.
Sequenex removes that orientation cost. Engineers placed through Sequenex complete our two-day SaMD-Trained Engineer program, covering IEC 62304 software lifecycle deliverables, ISO 13485 quality system expectations, and ISO 14971 risk management discipline, so they walk into your environment prepared for regulated work. This is the regulatory-fluent staff augmentation most firms cannot offer, and it is what separates MedTech-specialized staff augmentation from generic IT staff augmentation.
Start Scaling Your Development Team Today
Partner with Sequenex to access world-class development talent and regulatory expertise.
Let’s discuss your project needs and get started!
Get in touchLet’s discuss your project needs and get started!
SaMD and Connected Devices Software Experts
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