Establishing Guidelines for Medical Device Software Development Using Agile - Case: Start-up’s Infant Apnoea Monitor
Alarcón Roldán, José Manuel (2016)
Alarcón Roldán, José Manuel
Metropolia Ammattikorkeakoulu
2016
All rights reserved
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-201602292756
https://urn.fi/URN:NBN:fi:amk-201602292756
Tiivistelmä
Software has become a prominent part of modern medical devices. In order to ensure safety of patients and users of medical devices, health authorities around the world have produced a number of regulations that control the development, manufacturing and sales of medical devices. Software which is part of a medical device must meet the same safety and quality requirements as the device itself.
In Europe, Directive 2007/47/EC regulates the development and manufacturing of medical devices. International standardization organizations have produced harmonized standards such as IEC 62304 – medical device software – software life cycle processes to assist the manufacturers of medical devices in obtaining regulatory approvals.
In recent years a new way to develop software known as Agile has emerged. Agile methods are based on an iterative and evolutionary software development life cycle. Although regulators do not mandate what software life cycle should be used, most of the regulations and standards assume a linear life cycle, such as waterfall.
The Agile practices emerge from a common set of values and principles, such as quality of the software, productivity of the development teams and customer satisfaction. In this thesis we discuss how these values align with those of health authorities and regulators around the world.
In this thesis we Introduce the Agile SW development practices in the context of a medical device company. We will analyze the European Medical Device Directives and international standards. We then propose a set of guidelines for the development of medical device software based on Agile practices while complying with the international standards.
In Europe, Directive 2007/47/EC regulates the development and manufacturing of medical devices. International standardization organizations have produced harmonized standards such as IEC 62304 – medical device software – software life cycle processes to assist the manufacturers of medical devices in obtaining regulatory approvals.
In recent years a new way to develop software known as Agile has emerged. Agile methods are based on an iterative and evolutionary software development life cycle. Although regulators do not mandate what software life cycle should be used, most of the regulations and standards assume a linear life cycle, such as waterfall.
The Agile practices emerge from a common set of values and principles, such as quality of the software, productivity of the development teams and customer satisfaction. In this thesis we discuss how these values align with those of health authorities and regulators around the world.
In this thesis we Introduce the Agile SW development practices in the context of a medical device company. We will analyze the European Medical Device Directives and international standards. We then propose a set of guidelines for the development of medical device software based on Agile practices while complying with the international standards.