26 September 2019

Regulations for the prescription of footwear as medical device

Orthopedic footwear is part of the category of medical devices used in the conservative treatment of foot and ­lower limbs pathomechanics. For the custom-made medical device the manufacturer has to perform the design based on the prescription of a duly qualified medical practitioner that sets the specific design characteristics of the device. Quality management standards in the field of medical devices govern the entire process (or parts thereof) from ­design and development to delivery and provide technical support for their implementation.

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