ZSM Orthopedics manufactures orthopaedic custom-made shoes and size transfer- and control measurement equipment, on behalf of Orthopaedic shoe-technical companies all over the world. With our long-time experience in this Branche, our products have been developed and meet all the possibilities that are required to function as a foot orthosis, it fulfils the safety and performance requirements, aligned with how the employees of orthopaedic shoe-technical companies have designed and developed these products.

Our custom shoes are produced in various production locations around the world. With these companies, we drafted strict agreements regarding material applications, production methods & working methods and order handling and planning. All requirements of ZSM are carried out and extensively checked at our central logistics reception location regarding our quality criteria.

The requirements for production locations and quality controls are met, to ensure that our shoes comply with all laws and regulations. This also applies to the Medical Device Regulation 2017/745, which date of application was the 26th of May (MDR). Together with a number of loyal suppliers, we can meet these requirements of the MDR. Materials are only supplied from suppliers who can demonstrate that their products meet these requirements, and these (raw) materials are allowed on the European market.

For orthopaedic shoe technical companies and end users, we guarantee compliance with the requirements of the MDR, and we guarantee that our Quality Management system (QMS) complies with the ISO 13485:2016 standard. Within our QMS, among other things, the following is arranged:

  • Design & development
  • Material definitions
  • Production methods & working methods
  • Supplier selection & assessments
  • Quality assurance & controls
  • Traceability & re-call

ZSM hereby issues its custom-made orthopaedic shoes with a statement in several languages. You can download the statement via this site, fill it in and use it for your own file and to give to your customers when they obtain the custom-made shoes. With this statement, ZSM Orthopedics and the orthopaedic shoe-technical companies guarantee that custom-made shoes comply with all the requirements of the MDR.

You can download the MDR statement here.

Do you want usage and maintenance advice about your shoes? click here.

This website is realized by Webheads.