Flexible capacity
Embedded software, SQA, cyber or regulatory specialists billed hourly or on retainer.
Land on the urgent problem. Expand across the path to market.
A medical-software project rarely exists alone. The first job should solve the immediate pain while exposing the adjacent engineering, quality, cyber and regulatory work needed next.
EXPANSION LADDER
Map the lifecycle before the first proposal is signed.
The exact order changes by account, but the adjacency is the opportunity.
1Gap / strategy
codebase, regulatory path, software safety class, QMS state
2Engineering
algorithm hardening, GUI, cloud, embedded / application software
3Quality + V&V
requirements, RTM, testing, DHF, NPS validation
4Cyber + risk
threat model, SBOM, pen test, ISO 14971
5Submission + sustain
FDA/MDR support, QMS maintenance, updates and ongoing SQA
COMMON LANDING JOBS
Four doors into a longer relationship.
Each entry point creates a different natural expansion path.
AI / DIAGNOSTIC
Algorithm commercialization
Raw diagnostic logic → production software → IEC 62304 → V&V → cyber → submission.
REGULATORY
Submission-ready V&V
Test / traceability gap → DHF package → remediation → broader QMS / lifecycle support.
STARTUP
Turnkey QMS access
Use MedDev's ISO 13485 infrastructure → compliant development → validation → own QMS later.
CONNECTED DEVICE
Cyber hardening
Threat model / SBOM / testing → software remediation → risk management → submission support.
LEGACY DEVICE
Audit / gap remediation
Code / documentation gaps → DHF patching → MDR/FDA updates → ongoing SQA.
CAPACITY
Staff augmentation
Embed specialist talent → prove value → expand into defined projects or turnkey ownership.
COMMERCIAL SHAPES
Match the engagement to the risk the customer wants to transfer.
Different buyers want different levels of ownership.
Defined outcome
Fixed-scope development, V&V, remediation or submission package delivered by milestones.
Speed without full buildout
Use existing ISO 13485 / ALM infrastructure to begin compliant work before building internally.