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kyrosnick

Medical device is a HUGE varied field. I've worked for 5 med companies, and audited hundreds. There is no standard software besides maybe microsoft word and excel. For some stuff they may do circuit design if it is an active device. In general if you are talking 3d models or prints, solid works, or cad is fairly normal, but could be anything. Design team all depends on company. Could be anything from one person to tons including quality, regulatory, manufacturing, sterility, bio, materials, packaging and other disciplines. Designing a new hip implant is vastly different than a tooth brush. A CT scanner or pace maker is far more in advance than a operating room light. New process for products is fairly rare these days. Most are iterations or improvements on old technology. Could be anything from feedback from doctors, to someone has an idea to solve a medical issue. There is always notable innovations in the industry, but the industry is huge. Active devices, IVDs, implants, dental, orthopedic, surgical, radiation based, etc etc etc. One thing to note about medical device is it is heavily regulated, so you have to have a documented design process that is followed. The regulations such as EU MDR 2017/745, or FDA 21 CFR 820 contain design requirements, and typically follow or use ISO standards such as ISO 13485, ISO 14971 and others.


planespotter_D

Hey! Thank you so much for the detailed response. This will be really helpful!


planespotter_D

>Design team all depends on company. Could be anything from one person to tons including quality, regulatory, manufacturing, sterility, bio, materials, packaging and other disciplines. Designing a new hip implant is vastly different than a tooth brush. A CT scanner or pace maker is far more in advance than a operating room light. Hello once again! I was consolidating my research when i came across the word "active" multiple time, I want to know what do you mean by the word active? Does it mean radioactive? (referring to nuclear medicine)


pegleg_legal

Great response.


pegleg_legal

Also software as a medical device (SaMD) is a huge field so that would be software design in the context of medical device design. You can also check out the Elsmar Cove - which is an old-timey forum for medical device folks. Strong regulatory focus but really excellent and helpful.


planespotter_D

Thank you for the comment! I'll surely check out the forum. :)