Processes in place for ISO 13485 qualification
Confirmation from an independent auditing company now shows that Lumito has the processes in place to qualify for ISO 13485. The first step has been passed and the next step in the process is for the company to demonstrate that the processes are being followed in practice. The processes reflect that the company is well prepared for the requirements of the IVDR Regulation.- This was the first time that we were audited by an independent auditing company, a so-called notified body. I am both proud and pleased with the good work of our employees, which has meant that we are ready for step two