Embedded in your team
Engineers integrate directly into your workflows — your tooling, your sprint cadence, your engineering direction.
Staff augmentation
Specialized MedTech Engineers for Regulated Software Teams
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
Ready from day one
Every engineer completes the two-day SaMD-Trained Engineer program before assignment — IEC 62304 lifecycle deliverables, ISO 13485 quality expectations, ISO 14971 risk discipline.
Specialty depth
Subject matter expertise in CGM, biosensors, insulin delivery, connected wearables, cardiac monitoring, and remote patient monitoring.
Biosensor & BLE engineering
Deep experience in biosensor signal processing, BLE pairing reliability, and the connectivity protocols connected devices use.
Aligned to your regulatory environment
Engineers operate under 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 evolves — month-to-month flexibility through fixed-term arrangements.
Engagement models
Staff augmentation
Specialized engineers placed into your existing team under your engineering direction — hourly or monthly. For capability gaps you can’t hire fast enough, project ramps, and multi-quarter execution without permanent headcount.
Dedicated team subscription
Rent your own dev team: engineers, QA, DevOps, and a project manager — managed by Sequenex, working under your direction on your codebase. One plan, one price; flex size at the end of any billing cycle.
A named team, not a marketplace
Engineers who learn your codebase, your standards, and your domain — and stay with the program. Day-one productivity, predictable budgeting, no surprise invoices.
Specialty capabilities
Across every engagement model, engineers contribute to five capability areas — each fluent in the regulatory frameworks medical device software requires.
Connected device integration
BLE, NFC, WiFi, and cellular connectivity for biosensors, wearables, and connected medical devices.
Mobile & cloud engineering
Native iOS, native Android, and cloud-side engineers familiar with the regulated environment.
Cloud & edge infrastructure
HIPAA-ready cloud architecture and edge computing — in your AWS environment, under your operational control.
AI/ML engineering
Reproducible pipelines, version-control discipline, and familiarity with FDA AI/ML guidance for regulated software.
Automated testing & continuous delivery
Test engineering and DevOps specialists implementing continuous delivery / continuous compliance inside your organization.
Every engineer trained on medical device software discipline before assignment
Medical device software lives in a regulatory environment most engineers have never encountered. Generic staff-augmentation engineers spend their first three months learning what design history files are and why documentation discipline matters as much as implementation. Sequenex eliminates that orientation cost — every engineer completes the SaMD-Trained Engineer program before assignment and walks into your environment prepared for regulated work from the first standup.