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Flexible Engagement Models for Every Need
Choose the right model that fits your business needs, timeline, and budget.
Staffenza places ISO 13485 engineers. We deliver IEC 62304 SaMD, FDA-ready files, and Staffenza delivers IT Outsourcing for medical devices to VPs in 7–21 days. Dedicated teams perform IV&V testing. You keep product ownership, we run HIPAA aligned monitoring, AWS hosting, and deliver traceability with 85% retention.
7–21 Days
85%+ Retained
30–40% lower costHire pre-vetted SaMD and firmware engineers with ISO 13485 and IEC 62304 experience in 7-21 days, cutting ramp time by 60% versus traditional hiring.
Each candidate completes V&V scenario testing, IEC 62304 code reviews and FDA-aligned traceability checks, delivering a 95% first-time audit pass rate.
Teams embed into your QMS, follow HIPAA and SOC 2 practices, and achieve 90%+ retention at 12 months so your validation work stays consistent.
Scale by adding 3, 5, or 15 engineers with HL7 FHIR and AWS or Azure cloud skills, keeping your sprint velocity and meeting your MDR timelines.
Ship CI/CD pipelines that produce IEC 62304 traceability, 510(k) friendly artifacts and automated tests, letting your first commit meet audit criteria and cut rework by 40%.
Staffenza delivers IT Outsourcing for Medical Devices manufacturers and medtech teams, providing regulated software development, validation, and secure cloud hosting aligned to FDA, EU MDR, ISO 13485 and IEC 62304 requirements, producing traceable requirements, V&V artifacts, and security evidence for audits.
Start with a short pilot to prove processes and milestone cadence. Staffenza delivers IT Outsourcing for Medical Devices manufacturers, so you get predictable timelines, clear SLAs, IP protection, and managed post-market support.
Get a custom shortlist of domain-expert engineers matched to your Medical Devices project. Get your talents in days.
Ready for Medical Devices IT Outsourcing? Tell us the role, experience level, and budget you have in mind. We’ll match you with vetted candidates in 7 to 21 days.
Prefer to talk first? Reach out via email or phone and our team will respond within one business day.
Look for IEC 62304 experience. Expect 5+ years with embedded C, RTOS, Git, CI/CD, unit testing, traceability matrices, and V&V records mapped to FDA 510(k).
Deliver candidates in 7-21 days. Include a two-week paid trial, ISO 13485 checks, IEC 62304 audit records, AWS or Azure experience, and clear SLAs for uptime and defect rates.
Require ISO 13485 and IEC 62304. Prefer ISO 14971, IEC 62366, FDA 21 CFR part 820, HIPAA, GDPR, NIST guidance, and SOC 2 controls for connected devices.
Plan augmentation for peak phases. Verify vendor QMS, IEC 62304 experience, and a 90%+ code review pass rate before assigning V&V or cybersecurity work, and documented test protocols.
Choose partners with audit records. Start a pilot including traceability matrices, HL7 FHIR or DICOM integration proofs, penetration testing reports, and a 30-day SLA for critical fixes.
