General Terms and Conditions

ZSM Orthopedics

These General Terms and Conditions are part of our agreements, activities, and advice provided to and with you.

Our product terms can be found in the following section of this page.

General Terms and Conditions ZSM Orthopedics BV – Version 22 July 2025


1. ZSM Orthopedics B.V.

ZSM Orthopedics is based in Almelo and registered with the Dutch Chamber of Commerce under number 56850301. More information about our company can be found on our website: www.zsmorthopedics.com.


2. When do these general terms apply?

These terms apply whenever you purchase services and/or products from ZSM Orthopedics. This also includes advice related to those services and/or products.


3. Our products: quality and description

We show you all models of our orthopaedic footwear product family through the ZSM Orthopedics Brigante app, website, and printed or digital model books. Since the products are custom-made, variations in aspects such as colour and design may occur compared to the final products delivered. Subject to the order and accompanying technical specifications, the goods to be delivered must comply with the order in terms of quantity, description, and quality. They must be manufactured from proper materials and workmanship in line with applicable laws and regulations.


4. What price do you pay?

You pay the price communicated in advance via the price list. Prices are always exclusive of VAT and any shipping costs. Any deviations from this rule will always be discussed and confirmed in writing. The agreed price applies based on the established assumptions.

If these change (e.g., choice of material, colour, additions, or other modifications), additional costs may be charged. Furthermore, changes in taxes and/or external costs (e.g., VAT changes) must be applied by ZSM Orthopedics to your product’s price.


5. Payment default

Invoices must be paid within fourteen (14) days. This period is legally considered a strict deadline. If invoices are not paid on time, ZSM Orthopedics will send a reminder and subsequently follow the legal rules under the Collection Costs Act. Any collection costs incurred, including legal proceedings and attorney fees (both pre-litigation and during litigation), will be fully charged to you.


6. When can we terminate the agreement?

The agreement may be terminated immediately, without court intervention, if:

a) You pass away.

b) You are no longer legally capable of managing your assets and/or those of your company.

c) You or your company is declared bankrupt.

d) It is reasonably expected that our invoices will not be paid.

In all such cases, the costs of our work up to the moment of termination will be charged.

e) If you persistently fail to comply with applicable laws and regulations, including (European) rules on medical devices, quality, safety, and performance requirements. In this case, ZSM Orthopedics reserves the right to suspend or terminate the agreement immediately, without prejudice to its right to payment of outstanding orders, interest, costs, and any damages.


7. Our working method and delivery time

The production of orthopaedic products is labour-intensive. Any delivery time provided is always an estimate. While we strive to meet them, delays may occur. Delivery times are therefore not legally binding deadlines.


8. Warranty

Our Brigante collection has a warranty period of six (6) months on material and fit. Warranty only applies under normal use and not in cases of:

a) Normal wear and tear.

b) Damage caused by failure to follow usage and maintenance instructions.

c) Anatomical changes resulting in the product no longer fitting.

d) Adjustments made without authorisation by parties other than ZSM Orthopedics.

e) Deliveries in which materials provided by you are used.

Complaints must be reported within 21 days of the issue arising. Failure to do so voids the right to warranty.

Click here to read our warranty.


9. Liability / Force Majeure

If you suffer, have suffered, or will suffer damage caused by the actions and/or omissions of ZSM Orthopedics, the following applies:

a) All liability for damages is excluded unless covered by our liability insurance, and then only up to the amount paid out under that policy.

b) Damages must be reported in writing within three (3) months of becoming aware of them, including a description of the damage and its cause. If not reported within this period, the right to compensation expires.

c) Only direct damages (e.g., re-production of lasts) may be covered. Indirect or consequential damages (e.g., business loss, loss of turnover/profit, third-party damages) are excluded. ZSM Orthopedics is not liable for damage caused by reliance on incorrect or incomplete information provided by or on behalf of the client.

d) Liability insurance covers actions and/or omissions of the company and all its employees, including replacement due to lost products and lasts. If third parties (e.g., suppliers, doctors) cause damage, ZSM Orthopedics is not liable for that damage.

e) ZSM Orthopedics is never liable for damages caused by force majeure (events beyond reasonable control, e.g., strikes, terrorism, banking failures, pandemics, staff illness, supplier disruptions, ICT problems). If force majeure lasts longer than reasonably acceptable, the agreement may be terminated, but costs incurred up to that point will still be charged.


10. Privacy / Confidentiality / GDPR

ZSM Orthopedics values your privacy and ensures your personal data is handled carefully and in line with applicable regulations, including the General Data Protection Regulation (GDPR). See our Privacy Statement on our website for details, including your rights.


11. Intellectual property

You are, of course, entitled to use the products you have purchased and the services we provide. However, intellectual property rights (such as copyright, trademarks, design rights) remain with ZSM Orthopedics. These rights include texts, materials, models, etc.

This means you may not reproduce our products, use our name and/or models, or offer our products/services to third parties without our consent. All intellectual property rights are expressly reserved by ZSM Orthopedics.


12. Complaints and disputes

We aim for the highest quality. If you are dissatisfied, please call or email us right away.

If no solution is found, you may file a formal complaint. ZSM Orthopedics has a complaints procedure and an internal complaints coordinator. You can find this procedure on our website or request it free of charge.

If a dispute remains unresolved, it will be submitted to the competent court in Almelo, the Netherlands. Dutch law exclusively applies to all agreements. If any provision of these terms is found invalid, the other provisions remain in force. We will then seek to replace the invalid provision with one that matches its intent as closely as possible.

Product Terms

ZSM Orthopedics

These Product Terms apply between you (the purchaser) and ZSM Orthopedics (the supplier). In addition to these Product Terms, the General Terms and Conditions of ZSM Orthopedics BV also apply.

Product Terms ZSM Orthopedics BV – Version 22 July 2025

1. Ordering process

Products can be ordered via the ZSM Orthopedics customer portal, where you can order orthopaedic custom footwear (a medical device) and related measurement-transfer control products.

* ZSM Orthopedics ensures a wide, up-to-date range of materials compliant with all legal requirements.

* Brigante models are easily ordered via the portal; personal specifications must be entered.

* Product specifications are pre-filled by ZSM Orthopedics.

* Customers have access to the ZSM Orthopedics platform.

* The platform allows tracking of product progress and estimated delivery dates.

* ZSM Orthopedics communicates delivery times and delays via the platform.

* Shipment details and carrier tracking information are shared through the platform.

* Products are invoiced afterward in accordance with agreed prices.

Accounts for the portal can be requested at info@zsmorthopedics.com.


2. Pickup orders via our carrier

Through the customer portal, you can arrange pickup orders with our carrier. Accounts for this service can also be requested at info@zsmorthopedics.com.

Our carrier will collect packages from you and deliver them to ZSM Orthopedics. Packages must be adequately packed to prevent damage during transport.

Despite all precautions, damage, incomplete delivery, or loss may occur. In such cases, our insurance covers the damage, and we will contact you to resolve it, including re-manufacturing the order if necessary.


3. Product specifications and using customer-supplied materials

Materials and methods used by ZSM Orthopedics comply with the Medical Device Regulation (MDR 2017/745).

Materials supplied by customers (e.g., lasts, uppers, linings, leather, soles) must also comply with MDR requirements and be demonstrably suitable for orthopedic applications. ZSM Orthopedics may reject supplied materials if they do not meet regulations.

When customer-supplied materials are used:

* The customer is responsible for personalised fitting and measurements.

* The customer is responsible for materials compatibility and production methods.

Custom models provided by the customer (photo, pattern, design) are subject to technical feasibility assessment by ZSM Orthopedics. Acceptance may result in transferring final inspection and issuing of the conformity declaration to the customer.


4. Submission instructions

Orders must be submitted via the digital order form in the ZSM Orthopedics app.

Responsibilities:

* Customer selects desired options and specifications in line with available models.

* Customer determines last volume and alignment based on measurement.

* ZSM Orthopedics ensures software accuracy for proper order placement.

* Standard modelled lasts must be included with each order.

* Requirements for lasts, orthotic insoles, linings, and uppers are detailed (clean, intact, labeled, adequately dimensioned, etc.).


Standard lasts must be:

- Labeled with the client’s name and/or last number

- Complete, undamaged, and free of irregularities and glue residue

- Easily separable

- Equipped with an injection point (typically 2/3 of the length from the back)

- Marked with shaft height (standard measured at the back, including supplement)

- Marked with medial closure line (standard 10 mm below back height)

- Marked with lateral closure line (standard 20 mm below back height)

- Indicating supplement sizing according to ZSM method

- Marked with model lines for the custom provision


Supplements must be:

- Labeled with client name and/or last number

- Complete and free of defects

- Detached from the last and preferably attached with two staples


Lining shoes must:

- Be submitted with corresponding lasts (powdered)

- Be complete, undamaged, and free of defects

- Have detached supplements, attached preferably with two staples

- Include enough leather for finishing (otherwise, edge tape will be used)

- Be adjusted for the requested collar


Shafts must:

- Be fitted on the last

- Be labeled with client name, last number, and left/right indication


5. Authorization to finish and adjust the product

Products are delivered either as complete medical devices or requiring final adjustments (e.g., unlasting, placing an insole). ZSM Orthopedics authorizes customers to perform minor personalisation adjustments without losing its role as manufacturer, such as:

- Unlasting.

- Placing a flat insole over or under the orthotic insole.

- Minor top adjustments to the supplement where the foot makes contact.

- Resoling with equivalent materials.

Not permitted:

- Functional modifications to uppers.

- Volume changes to the base product.

Unauthorised modifications void warranty and ZSM Orthopedics’ manufacturer responsibility. The customer must then perform final inspection and issue a conformity declaration.


6. Quality requirements

ZSM Orthopedics complies with MDR (2017/745) obligations for Class I medical devices, supported by a Quality Management System (QMS) certified under ISO 13485:2016.

This ensures compliance with:

* Design & development.

* Product specifications.

* Production methods.

* Supplier selection and review.

* Quality assurance and controls.

* Traceability and recall procedures.

Only EU-approved materials suitable for orthopaedic applications are used. Non-Brigante models use the same approved materials.


7. Complaints, traceability, and recall

Any deviations, complaints, or incidents must be reported immediately upon receipt. ZSM Orthopedics will act promptly, e.g., replacing material or correcting the product.

Serious complaints indicating potential harm to users may trigger a recall procedure, supported by ZSM Orthopedics’ traceability and recall system. Customers must cooperate with recall procedures.


8. Requirements for customers

Customers must have appropriate qualifications for fitting and ordering products. In the Netherlands, companies must meet the requirements set by health insurers.

Final adjustments or delivery-ready work must be performed at least under the supervision of an Orthopedic Shoemaker Level 4.