Envisioning a Requirements Specification Template for Medical Device Software

Envisioning a Requirements Specification Template for Medical Device Software. Wang, H., Chen, Y., Khedri, R., & Wassyng, A. In The 15th International Conference of Product Focused Software Development and Process Improvement (PROFES 2014) , volume 8892, of Lecture Notes in Computer Science, pages 209 – 223, 2014. Springer International Publishing Switzerland.
abstract bibtex

In many health jurisdictions, software is considered to be ıt medical device software\/ (MDS), when it is used to analyze patient data in order to render a diagnosis or monitor the patient's health; when it is to be used by a patient to diagnose an ailment; or when it is used to deliver functionality for a medical device. Flaws in MDS can result in patient harm, including death. Legislators and regulatory agencies publish guidelines and regulatory standards that are aimed at ensuring the safety, security and dependability of MDS. These guidelines and standards universally agree that a complete and consistent requirement specification is vital to the success of medical device software. Moreover, we observe that regulators are shifting from being ıt process focused to being ıt product focused in their approval guidance. In this paper, we review challenges associated with requirements used in the development of MDS, current standards and guidelines relevant to MDS, and existing templates for requirement specifications. We then propose a set of design objectives for a `good' MDS requirements template and propose a template structure for MDS requirement specification fulfilling all the design objectives. Our template is, by design, tailored to facilitate the gathering and documenting of high quality requirements for MDS.

@inproceedings{WangChenKhedriWassyng2014,
	Abstract = {In many health jurisdictions, software is considered to be {\it medical device software\/} (MDS), when it is used to analyze patient data in order to render a diagnosis or monitor the patient's health; when it is to be used by a patient to diagnose an ailment; or when it is used to deliver functionality for a medical device. Flaws in MDS  can result in patient harm, including death.
Legislators and regulatory agencies publish guidelines and regulatory standards that are aimed at ensuring the safety, security and dependability of MDS. These guidelines and standards universally agree that a complete and consistent requirement specification is vital to the success of medical device software. Moreover, we observe that regulators are shifting from being {\it process focused} to being {\it product focused} in their approval guidance.  In this paper, we review challenges associated with requirements used in the development of MDS, current standards and guidelines relevant to MDS, and existing templates for requirement specifications. We then propose a set of design objectives for a `good' MDS requirements template and propose a template structure for MDS requirement specification fulfilling all the design objectives. Our template is, by design, tailored to facilitate the gathering and documenting of high quality requirements for MDS. 
},
	Author = {Hao Wang and Yihai Chen and Ridha Khedri and Alan Wassyng},
	Booktitle = {The 15th International Conference of Product Focused Software Development and Process Improvement (PROFES 2014) },
	Title = {Envisioning a Requirements Specification Template for Medical Device Software},
  	Series = {Lecture Notes in Computer Science},
   	Editor = {A. Jedlitschka et al.}, 
   	Publisher = {Springer International Publishing Switzerland},
   	Pages = {209 -- 223},
   	Volume = {8892},
   	Year = {2014}
}


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