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Methodology for the Design and Manufacture of Devices Medical, Related to the Sanitary Emergency Caused By Covid-19

Journal: International Journal of Mechanical and Production Engineering Research and Development (IJMPERD ) (Vol.10, No. 3)

Publication Date:

Authors : ;

Page : 12947-12954

Keywords : FDA; Medical Equipment; Development; Regulations; Patient Safety;

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The development of medical equipment is related to compliance with regulations, with the intention of safeguarding the physical integrity of patients, being able to ensure that a medical equipment complies with the regulations and can be registered with its respective authorization for use, it is a job long-term with the use of multiple resources. It is due to this characteristic that it is difficult for them to be able to register developments of medical equipment in most countries, either due to lack of infrastructure to carry out patient safety tests or due to the lack of regulations for the registration of medical equipment manufactured in their facilities of respective countries. In this research, a methodology is presented to be able to design medical equipment, considering the regulations and considerations regarding patient safety, as a result, a procedure based on the study of the market of similar equipment is presented in order to guarantee its possible registration and a matrix of technical information, to ensure compliance with regulations and patient safety.

Last modified: 2020-10-01 15:12:39