AI and Compliance Systems
for Regulated Healthcare .

SaMD is software intended to be used for medical purposes without being part of a hardware medical device. Examples include diagnostic apps, clinical decision support software, and treatment planning tools. SaMD requires regulatory approval (FDA clearance/CE marking) and must be developed under quality management systems like ISO 13485.

We develop software for medical device companies that goes through FDA and CE regulatory processes. We build with IEC 62304 lifecycle documentation, maintain audit trails, and create the technical documentation required for regulatory submissions. Our ISO 27001 certification supports the security requirements regulators expect.

Yes. We architect healthcare systems with HIPAA compliance from the start  encryption at rest and in transit, access controls, audit logging, and data governance. Our cloud deployments use HIPAA eligible services on AWS and Azure with appropriate BAA coverage.

We build production AI systems including NLP for clinical document processing, computer vision for medical imaging, predictive models for clinical decision support, and classification systems for diagnostics. We deploy these with proper validation, monitoring, and the documentation healthcare regulators require.

Security is foundational, not an add on. We’re ISO 27001 certified. We architect with defence in depth  network segmentation, encryption, access controls, audit logging, vulnerability scanning. For healthcare specifically, we align with HIPAA Security Rule requirements and implement technical safeguards appropriate to the data sensitivity.

7–10 business days from signed agreement to engineer embedded in your team.