The development, production and distribution of medical devices means that a number of standards and guidelines must be met. Our certificates for ISO 9001 and ISO 13485 were renewed in December. The ISO 9001 standard sets requirements for the quality system of an organization and the way in which the organization deals with the quality policy. The ISO 9001 certificate is the international hallmark for the quality management system.
ISO 13485 is the medical equivalent of ISO 9001 that has been specifically developed to help medical device manufacturers comply with relevant European legislation. In addition, Lode B.V. received an MDR certificate in January. We need this certificate to be able to supply medical devices now and in the future in Europe and a number of other countries where the MDR is accepted. The MDR certificate shows that we as a company can meet the stricter requirements of MDR.
Pieter Booi, Head of Quality Assurance: ‘Since May 26, 2021, the MDR has replaced the MDD that has been active since 1994. Legislation to replace an almost 27-year-old directive brings major changes. We are therefore proud to be one of the first group of manufacturers to have succeeded in complying with the MDR.’