How can Qserve help you?
IVDR Consulting Services
The In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746, which replaced the previous IVD Directive (IVDD) as of May 26, 2022, has brought substantial changes to the regulatory landscape for IVD manufacturers in the European Union. The regulation imposes stricter requirements for technical documentation and clinical evidence expands responsibilities across the supply chain and introduces new roles like the Person Responsible for Regulatory Compliance (PRRC). Therefore, many IVD manufacturers face significant challenges in complying with the new regulation.
At Qserve, we support IVD manufacturers in achieving IVDR compliance efficiently and effectively by providing expert guidance on IVD classification, gap analysis, and regulatory strategy. We provide pragmatic advice for generating the required clinical evidence including support with analytical and clinical study design and review of existing clinical data. We also assist in interactions with Notified Bodies, ensure supply chain actors meet regulatory obligations, and help to set up systems for UDI, EUDAMED registration, and post-market surveillance.
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