QRcompliance is a consultancy that specializes in quality and legal standards for in vitro diagnostic (IVD) medical devices. We offer our services to a variety of businesses, including device manufacturers, raw material suppliers, courier companies, and companies that outsource development or production processes.
Leveraging our extensive knowledge and experience, we guide our clients through the various laws, regulations, and guidelines related to IVD medical devices. We help them meet the regulatory and quality assurance requirements laid out in the IVDR/MDR.
In addition to assisting with ISO 13485 compliant Quality Management System (QMS) and the CE marking process for IVD devices, QRcompliance also provides instructional guides covering various aspects of the IVDR. These guides come with practical templates to help you create compliant documents. Check out our shop for more details.
Blogs about the IVDR and ISO13485: https://www.qrcompliance.nl/blogs/