As regulatory specialists, we are aware of the burden you are probably experiencing in making your In Vitro Diagnostic device compliant with the EU IVDR which comes into force next year. The EU IVDR affects all IVD medical devices and will bring about several major changes. As part of our commitment to helping businesses make this transition, we have compiled a checklist which you can download now to help you navigate the new and expanded regulations.
The checklist highlights all of the documentation that you will need in place for certification of your IVD device and will serve as a guide to help you achieve ongoing compliance. In conjunction with this checklist, we are also able to provide you with bespoke strategies to bring your business up to speed. We are currently working with businesses from the United States, India, and throughout Europe to ensure that they are ready for the deadline in May of 2022.