Medical device companies need more than a CRM.

Agamin partners with medical device manufacturers, diagnostics companies, and connected health organisations to deploy purpose-built digital infrastructure across the full device lifecycle — from launch through post-market management.

THE CHALLENGES

MedTech sits at an intersection generic platforms weren’t built to handle.

MedTech operates under demands generic platforms can’t meet.
Regulatory frameworks like FDA MDR, EU MDR, and ISO 13485 require strict compliance and traceability. At the same time, field service operations, HCP engagement, and device lifecycle management demand specialised workflows.
Add connected devices generating real-time data, and the complexity grows further.
Agamin is built for this environment—combining regulatory depth with scalable Salesforce architectures, so compliance and performance work together, not against each other.
Healthcare Dashboard Mockup
WHAT AGAMIN BRINGS

End-to-end digital infrastructure
for the MedTech operating environment.

1.

Device Complaint Management

MDR-compliant intake and investigation workflows—with reportability logic, signal detection, and full audit trails. Compliant, real-time, and decision-ready.
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2.

Field Service & Asset Management

Preventive maintenance, dispatch, inventory, and SLA tracking—built for large-scale device fleets. From reactive fixes to proactive uptime.
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3.

Post-Market Surveillance

EU MDR-aligned vigilance, PSUR, PMCF, and literature monitoring—structured for audit readiness. Compliance that drives product insight.
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4.

Regulatory Document Management

510(k), PMA, and CE Mark lifecycle management with version control and submission-ready workflows. One source of truth for regulatory teams.
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5.

HCP Education & Adoption

Training, certification, and adoption tracking for complex devices and procedures. Faster proficiency. Stronger adoption.
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Key
Capabilities

  • MDR-compliant device complaint management, reportability determination, and signal detection
  • Salesforce Field Service — preventive maintenance, corrective service, SLA, parts management
  • Post-market surveillance — PSUR, PMCF, EU MDR Articles 83–85 vigilance reporting
  • 510(k), PMA, CE Mark document lifecycle and submission package management
  • HCP education programme management — scheduling, competency tracking, adoption analytics
  • Connected device IoT integration via FHIR Device Observation with intelligent alert routing
  • Clinical affairs — scientific evidence management and HCP scientific engagement
  • ISO 13485 and IVDR compliance workflow support
  • Salesforce Health Cloud and Field Service implementation and optimisation