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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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ISO 9001:2026 has been published: translate ISO 9001:2026 developments in your supply chain into effective ISO 13485 supplier controls.
Understand how EUDAMED and Swissdamed differ, where their data aligns and how to prepare for both 2026 registration deadlines.