NDLI: Certification and regulatory challenges in medical device software development

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Content Provider	ACM Digital Library
Author	Hrgarek, Nadica
Abstract	The critical nature of safety in medical device software requires a repeatable and compliant software engineering process. This process should take into account the whole development life cycle, risk management, and software verification and validation activities that would commensurate with the device's complexity and risk. This paper discusses some of the key challenges medical device manufacturers are facing in the development and certification of medical device software. These challenges include: compliance with the EU and US regulatory requirements for medical device software, making software development and maintenance processes more agile in the medical device regulatory environment, integrating usability engineering process/human factors into software development, regulation of networked medical devices and mobile medical applications (apps). The MED-EL case study highlights some of the challenges described in this paper, and the approaches taken to overcome these challenges.
Starting Page	40
Ending Page	43
Page Count	4
File Format	PDF
ISBN	9781467318433
Language	English
Publisher	Association for Computing Machinery (ACM)
Publisher Date	2012-06-04
Access Restriction	Subscribed
Subject Keyword	Medical device software Mobile medical apps Regulatory compliance Usability engineering
Content Type	Text
Resource Type	Article

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
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Certification and regulatory challenges in medical device software development