Certification
Confidence in Every Step
At MyFoot, we believe that quality does not begin when a shoe is finished. Quality starts much earlier: with the design, the selection of materials and components, the way a product is developed and manufactured, and the controls carried out throughout the process.
That is why we pay attention to every step. From the initial development of a model to its final delivery, we work with clear procedures, quality controls and requirements that are appropriate for our products and the markets in which we operate.
Our MyFoot products are also assessed and documented according to the applicable requirements and standards within the field of orthopaedic footwear and medical devices.
For us, quality therefore means more than simply having a good finished product. It means being able to demonstrate how a product was developed, which materials and components were used, how quality is controlled, and how we manage risks and areas for improvement.
That is why we continue to invest in our products, processes and employees. In this way, we work every day towards reliable products and the level of quality you can expect from MyFoot.
But which certifications, markings and quality systems are important in this process? And what do they actually mean for you as a user?
NVOS Marking
All MyFoot models have been approved according to NVOS requirements and carry the NVOS marking.
But what does the NVOS marking represent?
The NVOS marking is linked to established quality criteria for Orthopaedic Shoes Type B (OSB). During the assessment, various aspects that are important for the quality and functionality of the footwear are evaluated.
This includes, among other things:
- the last and fit;
- the available foot space;
- the construction and support of the heel;
- the stability of the footwear;
- flexibility;
- the finishing;
- the quality of the materials and construction used;
- and the durability of the footwear.
The assessment is carried out according to an established inspection procedure by NVOS-Orthobanda.
The marking is therefore more than simply a designation on the shoe. It indicates that the relevant model has been assessed against specific quality criteria for OSB footwear.
What does this mean for you?
The NVOS marking gives you additional assurance regarding the quality of the relevant MyFoot model. It means that the model has not only been developed and assessed by us, but has also been tested against established criteria within the industry.
In practice, this means that the assessment does not only consider what a shoe looks like. It also considers aspects that you, as the user, actually experience: how the shoe fits the foot, how much space the foot has, how stable the shoe is, how the heel is enclosed, and how the shoe is constructed and finished.
A simple example: a shoe may look excellent on the outside, but for an orthopaedic shoe model, appearance alone is not sufficient. The fit, stability, construction and finishing must also meet the applicable quality criteria.
For you, the NVOS marking therefore primarily means that you can rely on a model that has been assessed against specific, predefined quality criteria for OSB footwear.
MDR
Our entire collection of MyFoot footwear complies with Regulation (EU) 2017/745 on medical devices (MDR), supporting the provision of safe and effective medical devices.
What does the MDR mean?
MDR stands for Medical Device Regulation. It is the European regulation governing medical devices. The MDR contains rules and requirements intended to ensure the safety, quality and reliability of medical devices.
The regulation goes beyond the finished product. It considers the entire lifecycle of a medical device: from development and design through manufacturing, control, documentation, use and follow-up.
Topics such as product safety, risk management, technical documentation, traceability and control are all part of these requirements.
For MyFoot, this means that quality and safety are not only addressed at the end of the production process. They are part of our way of working from the moment a product is developed.
For example, we consider potential risks during development, the properties of materials and components, how the product is manufactured, and which controls are required to monitor quality.
Product documentation is also an important part of this process. It must be possible to demonstrate which applicable requirements the product meets and how quality is monitored throughout its lifecycle.
What does this mean for you?
For you, the MDR means that a MyFoot product is not assessed solely on the appearance or performance of the finished shoe. Throughout the process, attention is given to safety, quality, risks and control.
You can compare this to a car: it is not enough to check whether the car looks good when it leaves the factory. The components used, manufacturing process, safety requirements, inspections and documentation are also important.
For a MyFoot product, this means that attention is also given to the materials and components used in the product and to the way in which the product is developed and manufactured.
For you, this provides additional assurance that quality and safety are structurally integrated into the development and manufacturing process. It is therefore not about a single inspection at the end, but about a process in which compliance with applicable requirements is assessed at different stages.
CE MARKING
The CE marking is a familiar symbol found on many products in Europe. You will also find this marking on MyFoot products.
But what is CE?
CE stands for Conformité Européenne. The CE marking is a visible indication that a product complies with the applicable European legislation and that the required conformity assessment procedure has been completed.
It is important to note that CE does not simply mean that a product has reached a particular level of quality. The CE marking relates to compliance with the applicable legal requirements for the product concerned.
For MyFoot, this means that the relevant products have been assessed and documented according to the European legislation applicable to those products before being placed on the market.
Depending on the type of product and the applicable legislation, different areas may be relevant, such as:
- safety;
- performance and functionality;
- risk management;
- product documentation;
- traceability;
- manufacturing and quality control requirements;
- and other specific legal requirements applicable to the product concerned.
The CE marking therefore indicates that the relevant European conformity assessment procedure has been followed for the product.
What does this mean for you?
The CE marking provides assurance that the relevant MyFoot product is placed on the market in accordance with the European legal requirements applicable to that product.
This means, for example, that consideration is given not only to the finished product, but also to the requirements arising from European legislation regarding safety, performance, documentation and risk management.
A simple example: when you use a MyFoot product, you want more than a shoe that is comfortable and functional. You also want to know that the product has been developed in a controlled and demonstrable manner and that the relevant legal requirements have been taken into account.
The CE marking provides a visible indication of this. It is important to emphasise, however, that the CE marking is not a general quality mark or quality award. It indicates that the applicable European legal requirements have been met and that the required conformity assessment procedure has been completed.
ISO 9001
A quality management system that continuously improves.
ISO 9001 is an internationally recognised standard for quality management systems. The standard focuses not only on the finished product, but primarily on how an organisation organises, controls, monitors and continuously improves its processes.
For MyFoot, this means that quality is part of the way we work every day.
Within a quality management system, attention is given to, among other things:
- clear and controlled processes;
- clearly defined responsibilities;
- documented procedures and working methods;
- identifying and managing risks;
- identifying opportunities for improvement;
- customer-focused working;
- inspections and evaluations;
- learning from experiences and non-conformities;
- and continuously improving processes.
ISO 9001 therefore helps us ensure that quality is not treated as a one-time inspection at the end of the production process. Quality is a continuous process in which we continue to monitor, evaluate and improve.
What does this mean for you?
For you, ISO 9001 primarily means that quality does not depend on a single inspection or a single employee. We work with documented processes, responsibilities and controls to systematically monitor and maintain quality throughout the organisation.
A simple example: when an inspection identifies that a particular working method could be improved, the process does not stop at identifying the deviation. We look at why the problem occurred, what can be changed and how we can prevent the same problem from occurring again.
Another example is the evaluation of customer feedback. When several customers indicate that a particular aspect of a product or service could be improved, that information is valuable. Within a quality management system, such feedback can be used to further improve processes, products or working methods.
For you, this means that we do not only ask: “Is this product good today?” We also ask: “How can we make sure that our products and the way we work are even better tomorrow?”
ISO 9001 therefore supports us in taking a structured and professional approach to quality. The goal is to make processes manageable, identify deviations and risks at an early stage, and continue improving.