ORTHOPEDIC FOOTWEAR
Orthopedic footwear is a medical device designed for the prevention, control, treatment or alleviation of a disease, injury, or disability.
The safety of orthopedic footwear must be evaluated by identifying hazards and assessing the associated risks according to procedures defined in ISO 14971.
HOW TO PROCEED?
Orthopedic footwear must comply with the provisions of Regulation (EU) 2017/745.
Our laboratories conduct tests in accordance with the following standard: Our laboratories conduct tests in accordance with the following standard:
Our laboratories conduct tests in accordance with the following standard: Our laboratories conduct tests in accordance with the following standard:
UNI 11533
Orthopaedic footwear as standard, prepared or insole – Safety and performance requirements and test methods.