Saturday, 11 June 2016

Medical device manufacturers: question about liability/disclaimers

 

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My device is built, the patent claims are rolling. It's a tool for physical therapy, FDA Class I (least regulated possible). It basically attaches to a person's legs and helps the PT facilitate certain movements. There is very little room for injury/accident. However, I have been told by my university business mentor to look into legal disclaimers of use...A form, I presume, which I would require each potential customer to sign, saying "I won't sue you if I get hurt using this device."

To my surprise and dismay, I can't find shit about this using Google. I'm not sure if I even know the right terms to search. I keep getting all sorts of legal precedents and information on how some medical device manufactures have been sued and how they are protected (generally) by law in manner X,Y,Z. Nothing to actually help me figure out if I really need such a form, or its nature.

Do I need this sort of protection?

Is it something simple enough that I can download a template online and customize it?

Do I need a lawyer?

Any help at all is much appreciated.

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