Industries · Healthcare & medtech
Software for healthcare providers and device manufacturers
Clinical software carries patient risk, and regulators treat it accordingly. We build hospital platforms, diagnostic tools and software as a medical device under the design controls that MDR, FDA and national authorities expect to see.
Regulatory pressure
Intended use and classification determine the evidence burden. A misclassified feature can invalidate a submission, and undocumented change history can hold a release for months.
Applicable standards
What we deliver
SaMD development
Classification support, software safety class determination and lifecycle execution under IEC 62304 from concept through post-market.
Clinical platform engineering
EHR-adjacent systems, patient portals, scheduling and clinical decision support integrated over FHIR, HL7 v2 and DICOM.
Device connectivity
Firmware-to-cloud pipelines, telemetry ingestion and remote monitoring built with segregation, integrity checks and audit trails.
Cybersecurity documentation
Threat modelling, SBOM management and vulnerability handling aligned to premarket cybersecurity guidance.
Documentation set
Evidence delivered with the software
- —Software development and maintenance plan
- —Requirements and traceability matrix
- —Risk management file (ISO 14971)
- —Verification and validation reports
- —SBOM and cybersecurity documentation
- —Design history file contributions
Contact
Start with a regulatory gap analysis
Describe the system, the market and the framework you are held to. We reply with an assessment scope, timeline and the documentation you would receive.
General enquiries
hello@softsoft.kzAudit & compliance
compliance@softsoft.kz