W
Watchwait
We manufacture a Class IIa medical device & maintain compliance to 60601-01 2nd edition. We have no intentions of claiming compliance with the 3rd edition of this standard until absolutely necessary & we gave have time in that regard.
However, my question is in regards to 62366 Usability Engineering for medical devices standard. We have a current ISO 13485 certification & ship product to the EU. Our product Technical File has been successfully reviewed by our Notified Body, and we do not reference EN 62366 in the Essential Requirements checklist. We do reference compliance to 60601-01 2nd Edition. Given this, where does conformance to the requirements in 62366 enter our picture, if at all?
However, my question is in regards to 62366 Usability Engineering for medical devices standard. We have a current ISO 13485 certification & ship product to the EU. Our product Technical File has been successfully reviewed by our Notified Body, and we do not reference EN 62366 in the Essential Requirements checklist. We do reference compliance to 60601-01 2nd Edition. Given this, where does conformance to the requirements in 62366 enter our picture, if at all?