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I am the RAQA Manager of a small medical device firm and we are in the software portion of our design phase. I am posting to see if anyone can direct me to EU regulations which call out a max speed on power assist wheelchairs. We plan to market in Europe and the US and want to incorporate the different speeds into our software while we are working on the design.
I easily found the US regulations (6mph) but have had no luck finding similar regulations for the EU. I have also found what seem to be transportation laws for europe referring to max speeds of 8mph on roads and 4mph on paths for power wheelchairs/scooters but if possible I would like to see it called out in a medical directive or specific medical device reg. Any and all help is much appreciated. Thank you!
I easily found the US regulations (6mph) but have had no luck finding similar regulations for the EU. I have also found what seem to be transportation laws for europe referring to max speeds of 8mph on roads and 4mph on paths for power wheelchairs/scooters but if possible I would like to see it called out in a medical directive or specific medical device reg. Any and all help is much appreciated. Thank you!
