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Resource Center

Discover blogs, articles, webinars, and resources all in one place.

Stay informed with expert insights, guides, and industry updates through our curated collection of blogs, articles, webinars, and resources.

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Blogs

Latest blogs

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BlogIVDRCDx
Companion Diagnostic Clinical Trials: Navigating Regulatory Challenges and Opportunities in the US and EU

This blog explores the key regulatory challenges and practical considerations involved in developing companion diagnostics for clinical trials in the US and EU.

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BlogIVDR
Submit Your IVDR Class B / Class A-Sterile Application Before May 26, 2027

Class B and Class A-sterile IVDs now need notified body sign-off. Get the 8-step plan to apply before May 26, 2027, and what the IVDR 2.0 proposal could change.

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BlogRisk ManagementQMSMedical DevicesQA/RA
ISO 9001:2026 Has Been Published: What Does It Mean for Medical-Device Manufacturers and Their Suppliers?

ISO 9001:2026 has been published: translate ISO 9001:2026 developments in your supply chain into effective ISO 13485 supplier controls.

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Events

Upcoming events

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Event
Join Bianca Lutters at DIA Virtual Workshop on PMS and Clinical Evidence

Join the DIA Medical Devices and Drug-Device Combination Products Workshop: Post-Market Surveillance and Clinical Evidence with Bianca Lutters.  

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Event
Meet and Greet Qserve Experts at the Veeva MedTech Summit 2026

Meet and greet Iris Verboven and Celien van Lochem at the Veeva MedTech Summit 2026 in Amsterdam and discover the latest innovations.

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Event
Meet & Greet Gert Bos at the RAPS Netherlands Chapter In Person Event

Join Gert Bos at the RAPS Netherlands Chapter Event to discuss proposals by the European Commission, including MDR 2.0, IVDR 2.0 and the Digital Omnibus.

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