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limalo
@limalo
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Joined: Jan 21, 2017
Topics: 2 / Replies: 4
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RE: Significant or non-significant risk

Basically significant risk devices are to be use in supporting human life and present a potential risk to the patient's health. The potential harm to ...

8 years ago
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8 years ago
Replies: 19
Views: 3356
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RE: Discussion Topic: To trial or not to trial

Design validation ensures that devices conform to defined user needs and the intended use stated in the design input. I believe a diagnostic microscop...

8 years ago
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RE: Discussion Topic: State of your Organization

I work in a matrix organization, where employees may report to many managers, for example in my case I work as design engineer in a functional departm...

8 years ago
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RE: Discussion Topic: Share your project management experience

I work for a class I and II medical device company that carries out development, manufacturing and marketing of implant-based dental restorations. Unf...

8 years ago
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Replies: 73
Views: 5997