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4. Approach and method
Having defined the context and the issues at stake, we are now aware of the field that surrounds us. This understanding is the key to successful research and engineering.
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Approach and method
Summary
Bibliography
Websites
Barton F. Branstetter IV, MD Basics of Imaging Informatics: Part 1 & Part 2 https://pubmed.ncbi.nlm.nih.gov/17431128/ and https://pubmed.ncbi.nlm.nih.gov/17581896/ (pages accessed 1 er ...
Standards and norms
- ISO Medical device software – Software lifecycle processes - IEC 62304 - 2006
- ISO Medical devices – Applying risk management to medical devices - EN ISO 14971 - 2012
Regulations
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12 July 1993, p. 1)Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices.
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