Medical & Healthcare Software QA
Medical&Healthcare
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Software QA
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Medical software demands absolute precision.
Medical&Healthcare
At FortiQA, we test healthcare and medical applications with a deep understanding of regulatory requirements, patient safety, and risk mitigation.
At FortiQA, we test healthcare and medical applications with a deep understanding of regulatory requirements, patient safety, and risk mitigation.
At FortiQA, we test healthcare and medical applications with a deep understanding of regulatory requirements, patient safety, and risk mitigation.
Our approach combines structured manual validation, targeted automation, and standards-driven testing aligned with industry frameworks such as FDA, IEC, ISO, and HIPAA.
Our approach combines structured manual validation, targeted automation, and standards-driven testing aligned with industry frameworks such as FDA, IEC, ISO, and HIPAA.
Our approach combines structured manual validation, targeted automation, and standards-driven testing aligned with industry frameworks such as FDA, IEC, ISO, and HIPAA.
We help ensure your software is compliant, reliable, and audit-ready — without slowing down innovation.
We help ensure your software is compliant, reliable, and audit-ready — without slowing down innovation.
We help ensure your software is compliant, reliable, and audit-ready — without slowing down innovation.
Medical & healthcare testing coverage:
Medical&Healthcare
Regulatory compliance & validation
Regulatory compliance & validation
Regulatory compliance & validation
• Electronic signature compliance (FDA 21 CFR Part 11).
• Electronic signature compliance (FDA 21 CFR Part 11).
• Electronic signature compliance (FDA 21 CFR Part 11).
• Software lifecycle validation (ISO 62304).
• Software lifecycle validation (ISO 62304).
• Software lifecycle validation (ISO 62304).
• Risk control features (ISO 14971).
• Risk control features (ISO 14971).
• Risk control features (ISO 14971).
• Requirements-to-test traceability matrices (RTM) for regulatory audits.
• Requirements-to-test traceability matrices (RTM) for regulatory audits.
• Requirements-to-test traceability matrices (RTM) for regulatory audits.
• Audit evidence generation and documentation readiness.
• Audit evidence generation and documentation readiness.
• Audit evidence generation and documentation readiness.
Security, access & data governance
Security, access & data governance
Security, access & data governance
• Access control & audit logs (HIPAA + FDA).
• Access control & audit logs (HIPAA + FDA).
• Access control & audit logs (HIPAA + FDA).
• User role separation and least-privilege access enforcement.
• User role separation and least-privilege access enforcement.
• User role separation and least-privilege access enforcement.
• Data retention, archival, and deletion policy testing.
• Data retention, archival, and deletion policy testing.
• Data retention, archival, and deletion policy testing.
Clinical workflows & patient safety
Clinical workflows & patient safety
Clinical workflows & patient safety
• Safety-critical workflows — clinical workflows, medication dispensing, temperature monitoring.
• Safety-critical workflows — clinical workflows, medication dispensing, temperature monitoring.
• Safety-critical workflows — clinical workflows, medication dispensing, temperature monitoring.
• Workflow validation for clinical environments.
• Workflow validation for clinical environments.
• Workflow validation for clinical environments.
• Error handling, alerts, and fail-safe behavior verification.
• Error handling, alerts, and fail-safe behavior verification.
• Error handling, alerts, and fail-safe behavior verification.
• Release impact analysis for safety-critical changes.
• Release impact analysis for safety-critical changes.
• Release impact analysis for safety-critical changes.
Data integrity & interoperability
Data integrity & interoperability
Data integrity & interoperability
• Clinical data accuracy and integrity validation across systems.
• Clinical data accuracy and integrity validation across systems.
• Clinical data accuracy and integrity validation across systems.
• EHR/EMR integrations, HL7/FHIR message validation.
• EHR/EMR integrations, HL7/FHIR message validation.
• EHR/EMR integrations, HL7/FHIR message validation.
• Interoperability testing between internal clinical modules.
• Interoperability testing between internal clinical modules.
• Interoperability testing between internal clinical modules.
Medication & device-related systems
Medication & device-related systems
Medication & device-related systems
• Medication management systems (inventory, dispensing, temperature monitoring).
• Medication management systems (inventory, dispensing, temperature monitoring).
• Medication management systems (inventory, dispensing, temperature monitoring).
Reliability, stability & change management
Reliability, stability & change management
Reliability, stability & change management
• System behavior under partial failures (network loss, service outages).
• System behavior under partial failures (network loss, service outages).
• System behavior under partial failures (network loss, service outages).
• Regression testing after regulatory, configuration, or workflow changes.
• Regression testing after regulatory, configuration, or workflow changes.
• Regression testing after regulatory, configuration, or workflow changes.
Usability & environment readiness
Usability & environment readiness
Usability & environment readiness
• Usability testing for clinical staff to reduce human error risk.
• Usability testing for clinical staff to reduce human error risk.
• Usability testing for clinical staff to reduce human error risk.
• Environment-specific validation (test, staging, production parity).
• Environment-specific validation (test, staging, production parity).
• Environment-specific validation (test, staging, production parity).
Request a manual review.
Request a manual review.
Request a manual review.
Let our experts inspect your UI by hand.
Let our experts inspect your UI by hand.
Let our experts inspect your UI by hand.
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