A Novel University Course on Medical Devices Design and Certification at the University of Siena

Author:

Iadanza ErnestoORCID

Publisher

Springer Nature Switzerland

Reference13 articles.

1. Iadanza, E.: Clinical Engineering Handbook. 2nd (2019). https://doi.org/10.1016/C2016-0-04298-5

2. Miniati, R., Dori, F., Iadanza, E.: Clinical engineering: from devices to systems (2016). https://doi.org/10.1016/B978-0-12-803767-6.00015-5

3. Regulation (EU) 2017/745 of the European parliament and of the council of 5 April 2017 on medical devices, amending directive 2001/83/EC, regulation (EC) no 178/2002 and regulation (EC) no 1223/2009 and repealing council directives 90/385/EEC and 93/42/EEC (text with EEA relevance) (2017). https://op.europa.eu/en/publication-detail/-/publication/83bdc18f-315d-11e7-9412-01aa75ed71a1/language-en

4. International Electrotechnical Commission: IEC 62304:2006 medical device software software life cycle processes. International Standard 62304, International Electrotechnical Commission (2015). https://www.iso.org/standard/38421.html

5. International Organization for Standardization: ISO 14971:2019. International Standard 14971, International Organization for Standardization (2019). https://www.iso.org/standard/72704.html. Medical devices – Application of risk management to medical devices

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