IVDR Regulatory Services
How to achieve CE-IVD certification and ensure IVDR compliance of lab-developed tests
IVD laboratories for human diagnostics
Are you prepared for the IVDR?
The IVD Regulation does not prohibit laboratory-developed tests (LDTs) also known as In-house developed tests (IHT). Let us help you to navigate through the requirements introduced by the European IVD Regulation 2017/746.
Download our whitepaper on the IVDR regulatory requirements for the use of laboratory-developed tests and how to comply with them.
You need individual support?
IVD manufacturers
Do you know about the requirements and challenges of the IVD Regulation?
We can consult you in finding the best-fitting regulatory strategy for your IVD products.
We can support you in completing or reviewing your IVD Technical Files to ensure compliance to the IVDR (EU) 2017/746 and thereby enabling a smooth CE-IVD approval by a Notified Body.
We can perform a gap analysis of your Quality Management System and the requirements of IVDR (EU) 2017/746.
We can conduct mock audits and supplier audits to ensure you do not face surprises during your certification audit.