requirements engineering;model based requirements engineering;medical devices development;route to certification
Abstract
Medical devices design and development companies, have a product development cycle, heavily directed by compliance and standards. The stringent quality standards, and adherence to compliance certifications makes it difficult to quickly introduce new features. This means, that the industry needs to have a robust technology roadmap, not only from the perspective of technology maturity but from qualification aspects as well. Proactive thinking as well as change and impact analysis. There are several ISO standards referenced by engineering design and development of medical devices, such as, ISO 13485 which sets out the requirements for a quality management system in the medical device industry, including those related to design and development. ISO 14971 Focuses on risk management throughout the entire lifecycle of a medical device, including the design and development stages. It provides a systematic approach to identifying, assessing, and managing risks associated with medical devices. ISO 15189 outlines the criteria for ensuring that medical laboratories consistently produce accurate and reliable results, thereby contributing to patient safety and quality healthcare. Compliance with these and many other standards contributes to the overall safety, effectiveness, and quality of medical devices. The route to certification for medical devices involves compliance with regulatory standards, such as those set forth by organizations like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Overall, Systems Engineering is a critical discipline in the route to certification for medical devices. By providing a structured and comprehensive approach to development, emphasizing requirements management, risk mitigation, interdisciplinary collaboration, and compliance with regulatory standards, Systems Engineering contributes significantly to the successful certification of medical devices in a highly regulated and safety-focused industry. In this presentation the presenters focus on effective requirements engineering, ensuring that all functional and non-functional requirements are identified, documented, and managed. Clear and well-managed requirements are essential for achieving and demonstrating compliance with certification standards. Requirements engineering is a systematic process of eliciting, documenting, validating, and managing requirements throughout the development of a system. This process plays a crucial role in ensuring that a product or system meets its intended purpose and satisfies the needs of its stakeholders. Traditionally it may rely on text-based requirements definition, often leading to lengthy and less intuitive documents. Also it relies on individuals for traceability of information and hence is less efficient in handling changes. Model-Based Requirements Engineering (MBRE) is an approach that leverages graphical models to define, visualize, and analyze system requirements. MBRE thereby provides a more intuitive and structured way of capturing, managing, and communicating requirements. MBRE enhances communication, facilitates collaboration, and supports automation for tasks like documentation generation and validation. It is often more flexible in managing changes and offers advantages in complex systems where visualizing interdependencies is crucial. The session will highlight the application of MBRE approach applied to projects for medical devices companies. The project involved implementation and execution of MBRE process. SysML based models and requirements management formal tools were employed for implementation. Behaviour defined in disciplinary tools was used as required. Collaboration and communication among various disciplines such as engineering, biology, medicine, and regulatory affairs has improved the most. The visual nature of models has enhanced communication, reducing the likelihood of misunderstandings and ensuring that all stakeholders are on the same page regarding requirements. The MBRE process is further enabling the following in the projects 1. Clarity and Precision in Requirements Specification by developing system level artifacts which can be created for any layer of the system 2. Traceability, which is a key aspect of certification processes 3. Generation of test cases directly from the requirements models and early verification 4. Efficiency in Documentation by representing key requirements graphically, making it easier for both developers and regulators to comprehend and evaluate 5. Integration of risk analysis directly into the requirements engineering process 6. Aiding in the preparation of evidence required for certification submissions. Model-Based Requirements Engineering is thereby a valuable methodology in the development of medical devices, offering benefits in terms of clarity, traceability, change management, verification, and compliance with regulatory standards. Adopting this approach significantly contributes to a smoother and more efficient route to certification for medical devices.