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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

About Us

Pioneering healthcare technology and compliance solutions

Qualified Data Systems stands as a beacon in healthcare technology, delivering bespoke solutions to the life sciences sector. We specialize in software assurance, cybersecurity, and data science services, enhancing patient outcomes with precision and compliance. Our partnerships with medical, biotech, and pharmaceutical leaders reflects a shared commitment to pioneering advancements in patient care, quality, and safety.

Services

Customized solutions for every need

At Qualified Data Systems, our custom services help life science organizations achieve success. Trust us for precise solutions in a rapidly evolving landscape.

Services

Customized solutions for every need

At Qualified Data Systems, our custom services help life science organizations achieve success. Trust us for precise solutions in a rapidly evolving landscape.

Software Assurance Icon

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.

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Cybersecurity Icon

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.

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Data Science Icon

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.

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SOLUTIONS

Transformative solutions for business growth

QDS offers a comprehensive suite of solutions to drive productivity, profitability, and compliance. From business process optimization to managed services, trust us to empower your business with adaptive solutions designed for success.

FDA Pre-Market Submission Review

FDA Pre-Market Submission Review

Achieve FDA approval with our expert software pre-market submissions review solution.

AI/ML Model Development

AI/ML Model Development

Develop and maintain compliant, trustworthy AI/ML models for life sciences with our lifecycle assurance solutions.

Data Integrity Gap Assessment

Data Integrity Gap Assessment

Ensure compliance and data integrity by addressing critical gaps with our specialized assessment solutions.

System Compliance Review

System Compliance Review

Reduce compliance risks and ensure operational integrity with our compliance review for non-product software.

Forensic Investigations

Forensic Investigations

Swiftly resolve digital incidents with our forensic investigations, ensuring compliance and recovery.

Secure-By-Design Analysis

Secure-By-Design Analysis

Ensure your medical devices are secure by design with QDS’s specialized analysis solution.

Software Lifecycle Development

Software Lifecycle Development

Optimize software quality and compliance across the entire development lifecycle.

System Remediation

System Remediation

Resolve issues promptly and effectively with our expert remediation services.

Medical Device DHF Assessment

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

Cyber Risk Assessment

Identify and mitigate risks to safeguard your business with our risk assessment solutions.

Quality System Integration

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
Data Quality and Integrity Considerations for Robust AI/ML Models in Life Sciences

Data Quality and Integrity Considerations for Robust AI/ML Models in Life Sciences

In the life sciences industry, the development of Artificial Intelligence (AI) and Machine Learning (ML) models offers transformative potential, from advancing drug discovery to personalizing patient care. However, the success of these technologies’ hinges on the quality and integrity of the data they rely on.
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The Importance of Integrating AI/ML Activities Into the Software Development Lifecycle
The Importance of Integrating AI/ML Activities Into the Software Development Lifecycle

The Importance of Integrating AI/ML Activities Into the Software Development Lifecycle

As the adoption of Artificial Intelligence (AI) and Machine Learning (ML) continues to accelerate in the life sciences and healthcare industries, these technologies are becoming integral to the development of innovative software solutions. AI/ML models are increasingly used in applications ranging from diagnostics and personalized medicine to predictive analytics and operational efficiency improvements.
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Verifying the Effectiveness of Software Risk Control Measures and Mitigations Through Software Assurance Activities
Verifying the Effectiveness of Software Risk Control Measures and Mitigations Through Software Assurance Activities

Verifying the Effectiveness of Software Risk Control Measures and Mitigations Through Software Assurance Activities

Gen AI adoption spikes and starts to generate value.

In the development of medical device software, ensuring patient safety and compliance with regulatory standards is paramount. Central to this effort is the verification of software risk control measures and mitigations. Risk management, as outlined in ISO 14971, involves identifying potential hazards, assessing the risks associated with those hazards, and implementing control measures to mitigate those risks.
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