Healthcare & Life Sciences

Compliance-grade systems for healthcare and life sciences.

Regulated healthcare technology is unforgiving. We've delivered it — from clinical-trial management systems to FDA 21 CFR Part 11-compliant platforms handling electronic records and signatures.

Talk to us about PHI & compliance

What we do

HIPAA/HITECH-aligned architecture; BAAs on qualifying engagements

FDA 21 CFR Part 11 electronic records and non-repudiable e-signatures

Clinical-trial management systems (CTMS) and data-integrity controls

EHR/EMR integration and FHIR interoperability

SaMD lifecycle: ISO 13485, IEC 62304, ISO 14971 risk management

GxP (GMP/GLP/GCP) practices and audit-ready documentation

Representative outcomes

Part 11 delivered

A cloud-native, multi-tenant SaaS platform fully compliant with FDA 21 CFR Part 11.

Clinical systems

Led technology for clinical-trial and rare-disease research systems.

Relevant frameworks

HIPAA / HITECH (supported)FDA 21 CFR Part 11 (delivered)ISO 13485 / 14971 / IEC 62304

Related services

Compliance & Regulatory Cyber & Digital Security

Frequently asked questions

Can AxiomAim build HIPAA-compliant healthcare software?+

Yes. AxiomAim architects HIPAA/HITECH-aligned systems for handling PHI and executes Business Associate Agreements (BAAs) on qualifying engagements.

Does AxiomAim have FDA 21 CFR Part 11 experience?+

Yes. Its founder led delivery of a cloud-native, multi-tenant SaaS platform fully compliant with FDA 21 CFR Part 11, including electronic records, non-repudiable e-signatures, and immutable audit trails.

What healthcare standards does AxiomAim work with?+

HIPAA/HITECH, FDA 21 CFR Part 11, GxP (GMP/GLP/GCP), SaMD lifecycle (ISO 13485, IEC 62304, ISO 14971), and EHR/EMR interoperability via FHIR.

Let's talk about what you're building.

Whether it's a security gap, a compliance deadline, an AI initiative, or a full technology strategy — start with a conversation.

Talk to us about PHI & compliance Explore services