Case Study SaMD and IVD Medical Device Start-Up
Software as a Medical Device and In Vitro Diagnostic medical devices are subject to rigorous regulatory and quality requirements to ensure patient safety, data integrity, and clinical reliability. Start-up organisations developing SaMD and IVD technologies often face particular challenges due to limited internal regulatory resources, evolving systems, and the need to demonstrate compliance early in the product lifecycle. This case study describes the support provided by Quality Systems Now to a Queensland-based IVD medical device start-up seeking ISO 13485 certification and sustained regulatory compliance. The engagement was conducted within the framework of ISO 13485, ISO 14971, IEC 62304, and ISO/TR 80002-2, using a structured and scientific approach.
Company and Product Overview
The client was an emerging IVD medical device company developing a diagnostic kit supported by proprietary software. The software component was designed to review, process, and present patient medical results generated from the company’s IVD kit. As the software directly supported diagnostic decision-making, it met the definition of Software as a Medical Device and was therefore subject to both medical device quality system requirements and software lifecycle controls. Prior to seeking ISO 13485 accreditation, the organisation had established a preliminary quality management system but required expert review, validation support, and audit preparation to meet certification expectations.
Project Objectives and Scope
The primary objective of the project was to prepare the organisation for successful ISO 13485 certification while establishing a sustainable compliance framework for ongoing operations. Secondary objectives included strengthening risk management practices, ensuring software lifecycle compliance, validating critical processes, and developing internal capability through structured training. Quality Systems Now was engaged to provide end-to-end ISO 13485 support, including gap assessment, quality system review, validation oversight, training, and audit readiness activities. The scope of work was designed to be proportionate to the size, complexity, and risk profile of the organisation and its products.
ISO 13485 Gap Assessment and Risk Identification
The initial phase of the project involved a comprehensive ISO 13485 gap assessment of the existing quality management system. This assessment evaluated documented procedures, records, governance arrangements, and operational practices against ISO 13485 requirements. Particular attention was given to design and development controls, supplier management, document control, and post-market processes. Quality Systems Now identified gaps, nonconformities, and areas of regulatory risk, providing structured recommendations prioritised by impact and likelihood. This evidence-based assessment established a clear remediation roadmap aligned with certification requirements.
Review and Development of Quality Management System Procedures
Following the gap assessment, Quality Systems Now reviewed new and revised QMS procedures developed internally by subject matter experts within the organisation. The review process focused on technical accuracy, regulatory alignment, and practical usability. Procedures were assessed for consistency with ISO 13485 requirements and integration with related standards such as ISO 14971 and IEC 62304. Emphasis was placed on ensuring procedures clearly defined responsibilities, inputs, outputs, and records. This systematic review strengthened the robustness and coherence of the quality management system while preserving organisational ownership.
Risk Management and Software Lifecycle Alignment
Risk management was a central component of the engagement due to the diagnostic nature of the device and the inclusion of SaMD. Quality Systems Now supported alignment of the risk management framework with ISO 14971 and ISO/TR 80002-2, ensuring risks associated with software, data handling, and clinical interpretation were systematically identified and controlled. In parallel, software lifecycle processes were reviewed against IEC 62304 requirements. This included software classification, development planning, verification and validation activities, and configuration management. The outcome was a defensible, traceable linkage between hazards, software risks, and control measures.
Validation Program Review and Support
Process and software validation are critical to demonstrating that systems perform as intended under defined conditions. Quality Systems Now reviewed and supported the company’s validation program to ensure it met regulatory and scientific expectations. This included assessment of validation plans, protocols, acceptance criteria, and reporting structures. Validation activities were evaluated for completeness, objectivity, and traceability to requirements. The consultancy provided guidance on risk-based validation approaches appropriate for both the IVD kit and the supporting software, strengthening confidence in system performance and compliance.
Training and Competency Development
To support sustainable compliance, Quality Systems Now delivered structured training to company personnel across key regulatory standards. Training covered ISO 13485 requirements, ISO 14971 risk management principles, IEC 62304 software lifecycle expectations, and Good Documentation Practice. The training approach was designed to be practical and role-relevant, enabling staff to understand not only what the standards require but why those requirements exist. Building internal competency reduced reliance on external support and reinforced a culture of quality and regulatory awareness within the organisation.
Mock ISO 13485 Inspection and Audit Readiness
Prior to the notified body inspection, Quality Systems Now conducted a mock ISO 13485 inspection to simulate real audit conditions. The mock inspection assessed documentation, implementation, staff responses, and overall system effectiveness. Findings were documented objectively and categorised according to significance. This exercise allowed the organisation to experience the inspection process, identify residual gaps, and implement corrective actions in advance. Following initial certification, Quality Systems Now continued to support the company through annual mock inspections to maintain audit readiness and reinforce continuous compliance.
Outcomes and Ongoing Compliance Support
The structured support provided by Quality Systems Now enabled the company to approach ISO 13485 certification with confidence. The quality management system was strengthened, validation activities were aligned with regulatory expectations, and staff competency was demonstrably improved. Ongoing annual mock inspections and advisory support ensured the organisation remained prepared for surveillance audits and regulatory scrutiny. From a scientific and regulatory perspective, the project demonstrated the value of early, risk-based quality system development for SaMD and IVD start-ups.
Conclusion
This case study illustrates how targeted ISO 13485 support can enable a SaMD and IVD medical device start-up to establish robust, compliant quality systems and achieve audit readiness. Quality Systems Now provided gap assessment, QMS review, validation support, training, and audit preparation aligned with ISO 13485, ISO 14971, IEC 62304, and ISO/TR 80002-2. Through a scientific, evidence-based approach, the organisation was supported from pre-certification through ongoing compliance. Quality Systems Now continues to act as GMP and regulatory compliance specialists, supporting therapeutic goods manufacturers, testing laboratories, and biotechnology companies in meeting regulatory expectations and sustaining quality performance.
