Qualified for
Patient Safety
Product Quality
Data Integrity
IT Compliance
Regulatory Intelligence
Expert Guidance
Empowering MedTech Solutions Safeguarding Patient Data Leveraging Compliance Insights Harnessing Data Science Securing Medical Products Validating Information Systems
Software Assurance
Software Assurance ensures the reliability and functionality of life science software systems. This is crucial as software's role in medical devices and healthcare grows. We improve processes, adopt best practices, and align with regulatory guidelines to enhance software quality and compliance.
Cybersecurity
The cyber threat landscape is constantly changing, with new vulnerabilities emerging daily. To protect modern MedTech, a solid and proactive cyber defense is essential. This is where QDS shines. We provide end-to-end cybersecurity resilience services that span both pre-market and post-market stages. From integrating cybersecurity into your Quality Management System to risk management and Secure-by-Design methodologies, our approach covers the full product lifecycle — from development to operations and ongoing servicing. Cybersecurity is a continuous commitment, not just limited to the R&D phase.
Data Science
Data and insights are at the core of modern healthcare decision-making. A validated, consistent approach to data science projects can give you a strong competitive edge. Whether building a Data Lake for business intelligence or integrating cutting-edge AI/ML models, scalable and reliable solutions are essential for your most complex use cases. Our Data and Software Quality Engineering expertise ensures support throughout the process, from developing algorithms to employing advanced statistical techniques.
SOLUTIONS
Transformative solutions for business growth
FDA Pre-Market Submission Review
Achieve FDA approval with our expert software pre-market submissions review solution.
AI/ML Model Development
Develop and maintain compliant, trustworthy AI/ML models for life sciences with our lifecycle assurance solutions.
Data Integrity Gap Assessment
Ensure compliance and data integrity by addressing critical gaps with our specialized assessment solutions.
System Compliance Review
Reduce compliance risks and ensure operational integrity with our compliance review for non-product software.
Forensic Investigations
Swiftly resolve digital incidents with our forensic investigations, ensuring compliance and recovery.
Secure-By-Design Analysis
Ensure your medical devices are secure by design with QDS’s specialized analysis solution.
Software Lifecycle Development
Optimize software quality and compliance across the entire development lifecycle.
System Remediation
Resolve issues promptly and effectively with our expert remediation services.
Medical Device DHF Assessment
QDS DHF Assessment ensures that your design history files are thorough and compliant, meeting quality, safety and regulatory requirements.
Cyber Risk Assessment
Identify and mitigate risks to safeguard your business with our risk assessment solutions.
Quality System Integration
Ensure quality and compliance with our electronic quality systems development solutions.
Featured Insights
Catch up on the latest insights
Data Quality and Integrity Considerations for Robust AI/ML Models in Life Sciences
The Importance of Integrating AI/ML Activities Into the Software Development Lifecycle
