Medical Device Software Development - A Perspective from a Lean Manufacturing Plant

Author:

Cawley Oisín,Richardson Ita,Wang Xiaofeng

Publisher

Springer Berlin Heidelberg

Reference41 articles.

1. EU, Council Directive 93/42/EEC of the European Parliment and of the Council, Concerning Medical Devices, E. Council, Editor, Official Journal of the European Union (1993)

2. EU, Directive 2007/47/EC of the European Parliment and of the Council. Official Journal of the European Union (2007)

3. FDA. U.S. Food and Drugs Administration, http://www.fda.gov (accessed March 10, 2011)

4. RTCA, DO-178B, Software Considerations in Airborne Systems and Equipment Certification. RTCA (Radio Technical Commission for Aeronautics) (January 1992)

5. FDA, Code of Federal Regulations 21 CFR Part 820, U.F.a.D. Administration, Editor (April 2009)

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1. Triangulating Research Dissemination Methods: A Three-Pronged Approach to Closing the Research-Practice Divide;Software Technology: 10 Years of Innovation in IEEE Computer;2018-09-03

2. Business Process Reengineering Through Lean Thinking: A Case Study;Journal of Enterprise Transformation;2014-04-03

3. Regulated Software Development – An Onerous Transformation;Foundations of Health Information Engineering and Systems;2013

4. Lean Software Development – What Exactly Are We Talking About?;Lean Enterprise Software and Systems;2013

5. Improving Safety in Medical Devices from Concept to Retirement;Handbook of Medical and Healthcare Technologies;2013

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