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3. Industrial issues
Medical imaging is therefore part of a transdisciplinary and translational context, bringing together researchers, engineers and doctors, and posing a challenge for industry to effectively transfer knowledge and technology, while respecting the regulations inherent in medical devices. The stakes are as follows:
respond appropriately to the clinical problem posed, or in other words, articulate the technologies so that they can be used in the context that has been defined;
differentiate from the competition or from what already exists in order to enhance a product or create value;
create a controlled technological heritage (intellectual and industrial property) ;
comply with the regulatory aspects of medical devices, including the ability to...
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Approach and method
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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