Software Medical Device Expertise

Emma Law
27/01/2015 10:04

I am looking for some advice/consulting from an expert in software medical devices. We are looking to run a clinical trial of a dose prediction software, which is classed as a medical device. If anyone has any expertise in this area and has knowledge of ISO 14971, IEC 62366 and IEC 62304 please contact me.

Henny Koch
10/03/2015 09:28

Dear Emma, Can imagine your concern. The use of the ISO 62366 on suitability engineering is a usefull tool in this (depending on your concern). This guidance can be combined with a risk based approach following the ISO 14971. Please contact me directly to see where I can be of support. Regards, Henny

Dr Paul Hercock
03/08/2020 16:01

Hi Emma, We may be able to help you. Feel free to contact us or visit us at https://www.mantrasystems.co.uk if you still require some advice. We provide consulting services for medical device manufacturers in relation to the MDR.

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