5. Code of Conduct for Medical Devices
Van Raam has, as a supplier of medical devices, signed and obliged to comply with the Code of Conduct for Medical Devices.
6. MDR legislation
As of 26 May 2021 the new Medical Device Regulation (MDR) will go into effect. Initially this will not have a lot of influence on the products of Van Raam. Furthermore, Van Raam has been prepared for this since 2020. Due to COVID-19, the commencement of this new regulation has been postponed to 26 May 2021.
One of the most important changes in this law is that medical devices should have an improved traceability throughout its supply chain. For this, the unique number of each bike will be extended with a Unique Device Identification (UDI). The GS1-Barcodes that are needed for this are already available, and have to be present on Van Raam’s products as of 26 May 2025. This date is applicable to all products in category 1, such as Van Raam’s products.
The Basic-UDI-DI is included in the declaration of conformity as of 26 May 2021. Each product group such as Easy Rider 3, or Fun2Go has its own Basic-UDI-DI. In combination with the frame number, this Basic-UDI-DI forms the Product Identifier (PI) as regulated in the MDR. The Frame number and its corresponding barcode have always been placed onto the bike frame. This is a unique number for each bike. The barcode on the declaration of conformity and the frame number together form the UDI.
7. Innovar Innovation Hub
Van Raam is an initiator and participant of the Innovar Innovation Hub, which was started in 2012.
8. Member of Smart Industry East and BOOST Head Group
Many companies are currently involved in Smart Industry. However, only 5 companies - including Van Raam - form the 'BOOST Head Group'. BOOST is the Smart Industry Easy agenda for action and prepares the eastern area of the Netherlands for Smart Industry.
They are a source of knowledge and inspiration for other Smart Industry businesses. They have created an agenda for action that helps them integrate Smart Industry into the corporate culture of companies in eastern Netherlands.