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
In response to European legislation described in the Medical Devices Regulations (MDR), Van Raam has implemented the following activities:
- Classification of the products in accordance with Article 51 of Regulation 2017/745 and the classification rules in Annex VIII to this regulation;
- Updating, where necessary, the technical file of the products notified as medical devices, including reassessment of the product and safety requirements, the user manual and the CE Declaration;
- Establishment and implementation of a Post Market Surveillance (PMS);
- Appointing a contact person for compliance with laws and regulations;
- An (annual) Periodic Safety Update Report has been drawn up.
As of 26 May 2020, Van Raam complies with the new legislation and regulations.
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.