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 provides a custom-made medical device declaration for its custom orthopedic footwear. This declaration is available via the customer portal.

Within the sales order, you will find the option ‘Print MDR Form’. This form can be printed directly and handed over to the end user upon delivery of the custom-made shoes.

The MDR form also includes a QR code, allowing the end user to easily access the instructions for use.

With this approach, ZSM Orthopedics and orthopedic footwear specialists ensure that the custom-made shoes comply with the requirements of the European Medical Device Regulation (MDR).

You can download the Declaration of Conformity here.

Shoe Use & Maintenance

Would you like advice on the use and maintenance of your footwear? Click here.