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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.

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Our Full Range of Quality Assurance & Regulatory Compliance Services

To capture today’s opportunities, organizations need partners who can adapt and scale to meet their dynamic needs. DASH supports clients across the fundamental pillars of modern software engineering.

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 
  • HIPPA, SOC 2, HL7, FHIR, HITRUST & GDPR 
  • Quality Management Systems Implementation 
  • Regulatory Compliance Audits 
  • Tools/Frameworks Assessment & Integration 
  • Risk Assessment & Mitigation 

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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.

Find Out How Our Dedicated Regulatory Experts Can Help You? 

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Our Engagement Models

Tailored to suit your needs, our adaptable collaboration models offer short-term and long-term engagement options, enabling you to seamlessly scale resources as needed or control costs with sustained dedicated resources. 

Discover Our Tech Stack

Our Blogs

May 15, 2024

Dash Technologies Announces Strategic Collaboration with KeborMed to Propel Digital Health Solutions Forward

Company News
Medical Device
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December 15, 2023

What is Healthcare Technology Consulting and Why is it Necessary?

Medical Device
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October 18, 2021

How AI/ML is Revolutionizing Medical Device Industry

Medical Device
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