ZSM Orthopedics Almelo – MDR Compliance

ZSM Orthopedics manufactures orthopedic semi- and fully custom-made footwear as well as measurement-transfer and control tools, commissioned by orthopaedic footwear companies worldwide. With many years of experience, we have developed products that meet all the functional, safety, and performance requirements of foot orthoses, in line with the design and development input of orthopaedic footwear professionals.

Our custom-made footwear is produced at multiple production sites across the world. With each of these facilities, strict agreements are in place regarding:

* Material application

* Production methods and workflows

* Order handling and planning

All product and process requirements set by ZSM Orthopedics are strictly followed. At our central logistics hub, every product undergoes extensive quality inspections against our requirements.

MDR and Regulatory Compliance

The stringent requirements applied to our production sites and our quality control ensure that our footwear complies with the relevant laws and regulations governing medical devices, including the Medical Device Regulation (MDR 2017/745), which came into force on 26 May 2021.

Together with a number of fixed suppliers, we ensure full MDR compliance. Materials are sourced exclusively from suppliers who can demonstrably prove that their raw materials meet the regulatory requirements and are approved for use on the European market.

For orthopaedic footwear companies and end-users, we guarantee that our products comply with MDR requirements and that our Quality Management System (QMS) is implemented in accordance with ISO 13485:2016.

Quality Management System (QMS)

Implementation of this standard has been completed, and our non-certified system is fully operational. Within our QMS, the following are addressed:

* Design & development

* Product specifications

* Production methods & workflows

* Supplier selection & evaluation

* Quality assurance & controls

* Identification & traceability

* Complaints & recalls

Declaration of Conformity

ZSM Orthopedics issues a Declaration of Conformity for its custom-made orthopedic footwear in multiple languages. This declaration can be downloaded from our website, completed, and used in your own documentation. You may also provide this declaration to your customers when delivering the custom-made footwear.

Through this declaration, ZSM Orthopedics and the orthopaedic footwear companies jointly guarantee that the custom-made footwear meets all requirements of the European standard MDR 2017/745.

You can download the Declaration of Conformity here.

Shoe Use & Maintenance

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