Since the classification into risk classes must be decided for each individual medical device based on its intended purpose, it is inevitable to be able to safely apply all rules of the MDR and IVDR. While the IVDR comprises seven rules, a total of 22 rules apply to medical devices according to MDR.
Instead of manual application, an automated software solution can safely support you in this process. Because a structured and fine-granular solution can guide you through the classification process.
Our latest solution for you: BAYOOSOFT Themis – the future of technical documentation. With the help of the Documentation Guide, you are guided step by step through the classifier. In this way, you can easily determine the assignment of the risk class by answering predefined questions.
Read more about BAYOOSOFT Themis and the Documentation Guide here.