The revision includes updates to various sections and brings the content up-to-date. Additionally, clarification in wording and improved formatting is included.
What does this mean for you?
IVD manufacturers should review the updated paper to ensure their technical documentation meets current best practice expectations, reducing the risk of regulatory queries and facilitating smoother conformity assessments.
关于作者
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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