As you might know the new IVDR, coming into force on May 2022, will have major implications on your operations. The need of a notified body for app. 80% of products, even for existing ones, and the assignment of a Person Responsible for Regulatory Compliance (PRRC) are only some of them.
We at Expand Healthcare Consulting together with one of our partners have successfully mastered similar situations with our medical device clients – preparing for the change from MDD to MDR. Now, facing the upcoming challenges of the new IVDR, we have already bolstered our capacity and partnered with Expand Healthcare to support optimally our diagnostics customers.
Our goal is to provide high quality services. It is our beliefs that this can only be achieved with a deep understanding of our customers needs and pains. Therefore, we would be pleased if you would take 5 minutes to participate in our “IVDR readiness survey”.
What is in it for you? As a thank you for your participation we send you a white paper with key topics of the upcoming IVDR. Furthermore, if you are interested in, we will provide you with a market radar at the end of our survey. This might be helpful to evaluate your competitive positioning for Regulatory and Quality Management on national and international level.
We highly appreciate your participation and support! Please click on the link to participate in our anonymous survey.
Take part of the survey =>Click on the icon to start the survey!
Please take care and stay healthy.
Your Expand Healthcare Consulting Team