Connected Device Integration
BLE, NFC, WiFi, and cellular connectivity for biosensors, wearables, and connected medical devices.
MEDTECH STAFF AUGMENTATION: ISO 13485, IEC 62304, SOC 2
Specialized MedTech Engineers for Regulated Software Teams
Sequenex provides specialized engineering capacity to MedTech and digital health companies - engineers fluent in IEC 62304, ISO 13485, ISO 14971, and the documentation discipline FDA-regulated software requires. Hourly contract, monthly engagement, or fully managed dedicated team - engagement structured to fit your project, not the other way around.
Why Choose Sequenex?
Sequenex specializes in software engineering for regulated medical device companies, engineered under the rigor of our ISO 13485-certified QMS. Our engineers operate within the documentation, validation, and quality system discipline required by medical device software, without the orientation costs.
Embedded in Your Team
Engineers placed through Sequenex integrate directly into your team workflows — your tooling, your sprint cadence, your engineering direction.
Full Lifecycle Coverage
Our engineers can support any stage of the software development lifecycle with engagement models that match where your program is today.
Specialty Depth
Subject matter expertise in CGM, biosensors, insulin delivery, connected wearables, cardiac monitoring, and remote patient monitoring – the categories where our team holds the strongest domain knowledge.
Ready From Day One
Every engineer completes Sequenex’s SaMD-Trained Engineer onboarding before assignment — trained in IEC 62304, ISO 13485, and ISO 14971 disciplines.
Biosensor and BLE Engineering Depth
Our engineers bring deep subject matter expertise in biosensor signal processing, BLE pairing reliability, and the connectivity protocols connected medical devices commonly use.
Engineering Aligned to Your Regulatory Environment
Our engineers operate under the rigor of our ISO 13485-certified QMS, fluent in IEC 62304, ISO 14971, HIPAA, and SOC 2.
Engagement Flexibility
Adapt team size and skill sets as your project needs evolve — month-to-month flexibility through fixed-term arrangements, no long-term commitment required.
Diabetes Software Product SMEs
Engineers with subject matter expertise in CGM, insulin pen, and insulin pump software — the diabetes care category where our team holds its extensive domain knowledge.
Our Engagement Models
Staff Augmentation
Specialized engineers placed into your existing team under your engineering direction. Hourly or monthly contract structures, with engineers onboarded through Sequenex’s SaMD-Trained Engineer program before assignment.
Filling specialized capability gaps your team 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 program execution without permanent headcount commitment
Key Benefits
Enhance your team with specialized talent for regulated industries. Ideal for:
Engineers arrive ready to contribute to regulated software work, with the documentation discipline already in place
Engagement length matched to your project, not to vendor preference
Sequenex sources, trains, and supports each engineer through our specialty engineering team
Rent Your Own Dev Team by Subscription
What It Is
A monthly subscription that gives you a dedicated 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
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Mid-size medical device and digital health companies running a sustained engineering program – typically six months to multi-year – who want predictable cost and a named team without the management overhead of pure staff augmentation. |
Core promise
Day-one productivity from a team trained in a 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, no surprise invoices, no end-of-quarter renegotiation.
Rapid Staffing
We handle recruiting, onboarding, and team coverage so your program is productive from day one.
Scalable Capacity
Flex team size up or down at the end of any billing cycle, matching your program roadmap.
Engineering Under Our 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, your standards, and your domain - and stay with the program.
Specialty Capabilities Our Engineers Bring
Across hourly contract, monthly engagement, and dedicated team subscription, the engineers placed through Sequenex contribute to five capability areas — each fluent in the regulatory frameworks that medical device software requires.
Mobile & Cloud Engineering
Native iOS, native Android, and cloud-side 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 / continuous compliance practices inside your engineering organization.
Every Engineer 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 three 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 eliminates that orientation cost. Every engineer placed into a customer project completes our two-day SaMD-Trained Engineer program before assignment — covering IEC 62304 software lifecycle deliverables, ISO 13485 quality system expectations, and ISO 14971 risk management discipline. The engineer walks into your environment prepared for regulated work from the first standup.
This is what separates MedTech-specialized staff augmentation from generic IT staff augmentation. It's the work that happens before the engineer joins your team.
Add Specialized MedTech Engineers to Your Team
Whether you need one specialized engineer for a defined milestone or a fully managed dedicated team for a multi-year program, the conversation worth having is what your engineering needs look like and which of our three engagement models fits.
Discuss Your Engineering Needs
SaMD and Connected Devices Software Experts
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