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5. Summary
As we have seen, integrating an existing technology or developing a new technology using internal resources is an open and continuous process:
open, because very often the information comes from the outside anyway (even if it's just a publication), which potentially means integrating know-how or knowledge not acquired internally at the outset;
continuous, because as we can see, the degrees of maturity follow on from the technology's initial level of maturity. As each degree is reached, an evaluation is carried out, and progress is made not only in the level of industrialization, but also in the refinement of the technology's evaluation. Of course, this point needs to be put into perspective, depending on the objective defined at the outset, but since development work has a cost, it is very often preferable...
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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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