Software Assurance
Product Software
Safeguard Your Medical Device Software with QDS’s Tailored Assurance Solutions
In the highly regulated life sciences industry, ensuring the quality, safety, and compliance of software products is paramount. Qualified Data Systems (QDS) offers comprehensive Software Assurance Services tailored to meet the unique challenges faced by medical device companies developing SiMD, SaMD, and Multiple Function Device Products. Our services are designed to improve product quality, enhance compliance with regulatory standards, and ensure that products are reliable and safe for patient use.
Core Services
Software Lifecycle Assurance
Qualified Data Systems (QDS) is a leading provider of Software Lifecycle Assurance services, specializing in helping organizations optimize their software development processes to enhance quality, safety, compliance, and efficiency. We offer end-to-end solutions that encompass software process assessment, measurement, and improvement, ensuring that your software products are developed to the highest standards.
Core Capabilities
Software Process Assessment
- Comprehensive Process Evaluation: QDS conducts detailed assessments of your current software development processes, identifying strengths, weaknesses, and areas for improvement. Our assessments are based on industry best practices and frameworks such as CMMI, ISO/IEC 62304, 12207, IMDRF, and Agile methodologies.
- Gap Analysis: We perform gap analyses to compare your existing processes against industry standards and regulatory requirements, highlighting areas that require attention to meet compliance and quality objectives.
- Tailored Recommendations: Based on our assessments, we provide tailored recommendations to optimize your software development processes, ensuring they align with organizational goals and regulatory expectations.
Software Process Measurement
- Key Performance Indicators (KPIs) Development: We help organizations define and implement KPIs that accurately measure the effectiveness, efficiency, and quality of their software development processes. These KPIs provide actionable insights into process performance.
- Quantitative Data Collection and Analysis: QDS utilizes advanced data collection and analytics techniques to gather quantitative data on process performance. Our methodologies ensure that you have accurate, real-time metrics to guide decision-making.
- Benchmarking: We offer benchmarking services that compare your process performance against industry standards and peers, allowing you to identify areas for improvement and track progress over time.
Software Process Improvement
- Process Optimization: Leveraging the insights gained from assessments and measurements, QDS implements process optimization strategies tailored to your organization’s specific needs. Our approach emphasizes efficiency, quality, and regulatory compliance.
- Agile and DevOps Transformation: We guide organizations through Agile and DevOps transformations, ensuring that your software development processes are adaptable, responsive, and aligned with modern development practices. We characterize the robustness and integrity of CI/CD pipelines and help streamline your Continuous Integration/Continuous Deployment process, reducing time-to-market while maintaining high quality and compliance standards. We assist in executing AI/ML Ops integration with DevSecOps to help you fast track product delivery.
- Continuous Improvement Programs: QDS establishes continuous improvement programs that embed a culture of quality and innovation within your software development teams. These programs are designed to evolve with your organization, ensuring long-term success.
Regulatory Compliance
- FDA and International Standards Compliance: We guide you through the complexities of FDA regulations, including 21 CFR Part 820, IEC 62304, ISO 13485, and other relevant international standards. Our team ensures that your software development and documentation practices meet the stringent requirements set by regulatory bodies.
- Risk Management: Our risk management services, aligned with ISO 14971, help you identify, assess, and mitigate risks associated with your SiMD and SaMD products, ensuring that safety is embedded in every aspect of the software lifecycle.
- Technical Documentation and Audit Support: We assist in creating comprehensive documentation required for regulatory submissions, including Software Development Lifecycle (SDLC) deliverables, risk management files, and testing records. QDS also offers Inspection readiness and support to help you navigate inspections confidently.
Cybersecurity Assurance
- Implementation support for Secure-by-Design, Secure-by-Default, and Secure-for-Compliance principals and activities across the total product lifecycle including complex software supply chains from design to product obsolescence.
- Information Security Management System integration with Quality Management Systems including procedure development and training.
- Threat Modeling and Vulnerability Assessments: We conduct detailed threat modeling to identify potential security risks within your software. Our vulnerability assessments pinpoint weaknesses in your SiMD and SaMD products, providing actionable insights to enhance security. We stress test and verify the effectiveness of risk controls and mitigations.
- Secure Coding Practices: QDS promotes the adoption of secure development practices within your development teams, reducing the likelihood of vulnerabilities being introduced during development.
- Post-Market Cybersecurity Management: Our services extend beyond product launch, offering continuous monitoring and management of cybersecurity risks to ensure that your products remain secure throughout their lifecycle.
Data Integrity and Confidentiality
- Data Management Strategies: We help implement robust data management strategies that ensure the integrity, confidentiality, and availability of data used in or generated by SiMD and SaMD products.
- Data Privacy Compliance: QDS ensures that your software complies with relevant data privacy regulations, such as GDPR and HIPAA, safeguarding patient information and maintaining user trust.
- Data Integrity Audits: Our audits assess the accuracy and reliability of your data processes, helping to prevent data corruption and loss.
Artificial Intelligence and Machine Learning (AI/ML) Assurance
- Algorithm Validation: For SiMD and SaMD products incorporating AI/ML, we provide specialized services to validate algorithms, ensuring they operate as intended and comply with regulatory guidelines. We help you integrate these processes into your software life cycle.
- Bias and Fairness Assessments: QDS evaluates AI/ML models for potential biases, helping to ensure that your software provides equitable and accurate results across diverse patient populations.
- Explainability and Transparency: We assist in implementing explainable AI (XAI) methodologies, making AI/ML decisions transparent and understandable for regulatory bodies and end-users.
Value Proposition
QDS’s Software Assurance Services for Product Software offer the following benefits:
By aligning your software development processes with industry standards, we reduce the risk of regulatory non-compliance, facilitating smoother submissions and faster approvals.
Our focus on rigorous testing, risk management, and cybersecurity ensures that your SiMD and SaMD products are of the highest quality, safe for patient use, and resilient against cyber threats.
Our process improvement and CI/CD services help streamline development cycles, reducing time-to-market without compromising on quality.
With our AI/ML assurance services, your innovative software solutions are validated for safety, effectiveness, and regulatory compliance, positioning your company as a leader in medical technologies.