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Hi everyone,
Here's my question. I hope this is the right forum.
My company is producing an electronic medical device for use in operating rooms. We have been advised by the FDA that we will be a class I device. As a result, it looks like we won't need to comply with IEC 60601-1 for their sake.
Is there any other reason to comply when selling strictly in the US? Will hospitals perhaps demand it, even though the FDA does not? I realize that we will likely need it for overseas sales, but we don't intend to sell the current version of the product outside the US. We will be designing a version 2 in the near future for international sales, and would like to wait until then for 60601-1 if possible.
Thanks in advance for any insight you can offer.
Here's my question. I hope this is the right forum.
My company is producing an electronic medical device for use in operating rooms. We have been advised by the FDA that we will be a class I device. As a result, it looks like we won't need to comply with IEC 60601-1 for their sake.
Is there any other reason to comply when selling strictly in the US? Will hospitals perhaps demand it, even though the FDA does not? I realize that we will likely need it for overseas sales, but we don't intend to sell the current version of the product outside the US. We will be designing a version 2 in the near future for international sales, and would like to wait until then for 60601-1 if possible.
Thanks in advance for any insight you can offer.