QA & Regulatory Compliance: From Innovation to Certified Reality
Innovation must meet trust, safety and regulation—especially in regulated industries such as healthcare, MedTech and aerospace. At Dash Technologies, our QA & Regulatory Compliance service brings decades of experience in building quality systems, conducting validation, managing audits and delivering market-ready products.
Whether you’re developing software as a medical device (SaMD), connected hardware, or enterprise platforms with strict compliance demands, we provide robust QA engineering, documentation, risk management and lifecycle support. With Dash, your solutions aren’t just technically excellent—they’re certified, trusted and ready for global markets.
Our Quality Assurance & Regulatory Compliance Spectrum
Our QA & Regulatory Compliance Services includes:
- Quality Management Systems (QMS) Design & Implementation – ISO 13485, ISO 14971, FDA 21 CFR Part 11 compliant frameworks.
- Verification & Validation Engineering – software, firmware and system testing across functional, safety, performance and user domains.
- Audit Readiness & Regulatory Consulting – preparation for audits, submissions, evidence gathering and compliance strategy.
- Test Automation & Continuous QA – integrating automated test suites, regression testing and CI support for faster release cycles.
- Post-Market Surveillance & Risk Management – monitoring product performance, collecting real-world data, managing corrective actions and CAPAs.
- SaMD & Medical Device Compliance – end-to-end support for regulated products including documentation, traceability, version control and release management.
Our Quality Assurance Team Leads You Through Regulatory Compliance Tasks
From assessment and document creation through supplier quality management and QMS implementation, DASH collaborates with you. Our quality assurance and regulatory compliance strategy guides you in assessing, planning, and executing phase-appropriate quality programs for starting, scaling, and sustaining operations.
Our team supports your familiarity with medical standards and the regulatory process. We analyze standards and regulations to establish design requirements based on identified specifications.
Risk management is crucial. Our quality assurance experts ensure ongoing risk analysis and management activities throughout the development process.
Want to know how? Discover our Tech Stack right here ⟶
Our Full Range of Quality Assurance & Regulatory Compliance Services
Rely on expert guidance to navigate the complex global regulatory landscape and stay ahead of compliance challenges. Our proven expertise, knowledge, and processes deliver flexible solutions to meet rigid compliance requirements, ensuring regulatory compliance without compromise.
Device & Application Testing
- Multimedia & Audio/Video Testing
- Embedded System & Integration Testing
- Sensor Integration & Connectivity Testing
- Connected App & Edge Testing
- Product Performance & Functional Testing
- CI/CD & Device to Cloud Test Automation
AI/ML Testing
- Dataset & Feature Validation
- Model Validation & Performance Benchmarking
- Model Parameters Traceability
- ML Library Integration Testing
- Embedded Neural Network Application Testing
QA Automation
- Python & Selenium scripts
- Automation tools & frameworks integration
- Load & Scalability testing with Jmeter
- CI/CD DevOps tools integration
- Test coverage tools integration
Certification, Compliance & Consulting
- IEC 62304 & ISO 13485
- FDA 21 CFR Part 11 & CE
- HIPAA, SOC 2, HL7, FHIR, HITRUST & GDPR
- Quality Management Systems Implementation
- Regulatory Compliance Audits
- Tools/Frameworks Assessment & Integration
- Risk Assessment & Mitigation
Achieve Quality Assurance & Regulatory Compliance
Our team of proficient QA, regulatory consultants, and business domain experts conducts thorough gap/impact assessments, steering change management seamlessly across the entire product lifecycle.
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