Together for total footcare.

Law and regulations

Laws and regulations are playing an increasing role in our field. It is an important topic, which is why we think it is very important to inform our partners about it as well and completely as possible.

Law and regulations

MDR Medical Device Regulation

Within PLT, we are aware of current laws and regulations. When developing our products and services, laws and regulations run like a 'red thread' through our process. Thus (patient) safety (including MDR) of our customised products is paramount and this goes hand in hand with ease of use for the end user.

We play a role in the supply of hardware and software combined with the manufacturing process of customised products. We are responsible for these processes. We provide the organisation with documentation and guidelines, which are relevant to MDR laws and regulations.

ISO 13485 certified

At PLT Products, quality and safety are of paramount importance. Our quality management system complies with the international ISO 13485 certification - the standard for manufacturers and suppliers of medical devices. This certification ensures that our products and processes meet the highest requirements in terms of regulations, reliability and customer satisfaction. By working according to ISO 13485, we ensure that our medical devices are safe to use and that risks to patients are minimised.