Practical aspects of implementation of quality management system requirements for the medical footwear design

A quality management system in place and functioning can be certified by a neutral body, third party, that certifies compliance of the design process of the medical footwear to the reference specifications in this field. In states where pedorthics is developed, professional associations provide an accreditation of facilities that are operating in the design and production of pedorthic devices. Another option for conformity certification in the field of medical devices consists in demonstrating that quality management system (QMS) of the organization complies with the requirements of the standard reference in the field, respectively SR EN ISO 13485: 2016 "Medical devices. Quality management systems. Requirements for regulatory purposes". Design work carried out according to the requirements of this standard contributes to the development of medical devices complying with the regulations in this field for the benefit of the patient. This paper aims to present practical aspects of implementing the quality management system requirements for the design of medical footwear, applicable to small and medium companies.