BME520 Medical Software Part 1 PDF

Biomedical Devices Design and Troubleshooting (BME520 ) Chapter 5: Medical Software Claudio Becchetti, 1th Edition Dr. Qasem Qa...

Biomedical Devices Design and Troubleshooting (BME520 ) Chapter 5: Medical Software Claudio Becchetti, 1th Edition Dr. Qasem Qananwah 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 1  Chapter 5: Medical Software Part I: Theory Introduction Figure : Medical device architecture 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 2  Chapter 5: Medical Software Part I: Theory Introduction Figure : Medical software design model. 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 3  Chapter 5: Medical Software Part I: Theory Introduction A software product is a set of programs containing instructions and data that computers and programmable devices (e.g., microcontrollers, FPGAs etc.) read to perform specific functions. 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 4  Chapter 5: Medical Software Part I: Theory Introduction The firmware and the software running on PC based platforms share the same problems and they are often referred to generically as (medical) software in standards (e.g., IEC/EN 60601-1) and regulatory frameworks (e.g., EEC, 2007). 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 5  Chapter 5: Medical Software Part I: Theory Introduction In general, a medical software is a stand alone software used for medical purposes (diagnostic or therapeutic) a software component of a medical device (i.e., embedded software) a software which drives a device or influences the use of a Device a software that is an accessory of a medical device. 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 6  Chapter 5: Medical Software Part I: Theory Introduction Medical software must comply with national and regional laws. In the European Union (EU), software requirements are included in the Medical Devices Directive amended in 2007 (EEC, 2007). In the USA, the Food and Drug Administration (FDA) has increased its involvement in reviewing the development of medical device software (FDA, 2012). 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 7  Chapter 5: Medical Software Part I: Theory Introduction To reduce costs and risks of software development, a systematic approach to the analysis, design, assessment, implementation, testing, maintenance and reengineering of software has been defined, with the application of engineering to software. This approach gave birth to a new discipline known as ‘software engineering’ 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 8  Chapter 5: Medical Software Part I: Theory Introduction Software engineering (SE) may be defined as the application of a systematic, disciplined, quantifiable approach to the development, operation and maintenance of software, and the study of these approaches 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 9  Chapter 5: Medical Software Part I: Theory Main Concepts in Software Development There are different approaches to software development. In any case, most methodologies share a combination of the following stages of development: gathering requirements for the proposed solution analyzing the problem defining plans and design specifications for the software-based solution implementing (coding) the software testing the software deploying programs on the target environment performing maintenance, change management and error fixing 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 10  Chapter 5: Medical Software Part I: Theory Main Concepts in Software Development These stages may also be carried out in sequence (the so called ‘waterfall’), or they may be repeated over various cycles or iterations (a more ‘iterative’ approach) 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 11  Chapter 5: Medical Software Part I: Theory Main Concepts in Software Development Figure : Waterfall software design process. 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 12  Chapter 5: Medical Software Part I: Theory Regulatory Requirements for Software In recent years, regulatory bodies have increased their attention to medical device software since software is a growing component in medical devices. 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 13  Chapter 5: Medical Software Part I: Theory Regulatory Requirements for Software It has been seen that safety and performance of medical devices may be ensured only through a controlled software development process. Devices incorporating electronic programmable systems must be designed to ensure the 1. repeatability 2. reliability and 3. performance of these systems according to the intended use. 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 14  Chapter 5: Medical Software Part I: Theory The Process: a Standard for Medical Software With the rise of a new generation of software-empowered devices, a new regulation is in force governing medical device software development for all classes of equipment. With the growing importance of embedded systems, the focus has shifted to the reliability of software and to the associated device usage risk. As a result, the new IEC/EN 62304 has emerged as a global benchmark for the management of the software development life cycle. 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 15  Chapter 5: Medical Software Part I: Theory The Process: a Standard for Medical Software IEC 62304 is a standard for software design in medical products recognized by the European Union (i.e., harmonized) and by the US FDA. 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 16  Chapter 5: Medical Software Part I: Theory IEC/EN 62304 Overview Figure : Medical device objectives. 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 17  Chapter 5: Medical Software Part I: Theory IEC/EN 62304 Overview IEC/EN 62304 provides a framework of life cycle processes needed to safely design and maintain medical device software. This standard provides requirements for each life cycle step and process. 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 18  Chapter 5: Medical Software Part I: Theory IEC/EN 62304 Overview Figure : IEC 62304 relations with standards. 12/25/2022 BME520: Biomedical Devices Design and Troubleshooting Biomedical Systems and Informatics Engineering Department 19