News FDA Guidance: How to Prepare a Pre-Request for Designation (Pre-RFD) Read More » MedTech Europe Advocates for a Risk-Based Approach to PMCF under the MDR Read More » TEAM-NB Issues Updated Position Paper on IVDR Annex IX Changes to Companion Diagnostic Devices Read More » TEAM-NB & NBCG-Med: Call for Evidence on Digital Omnibus – Simplifying AI Regulation with Clarity and Sustainability Read More » FDA’s New Guidance on IVD Enforcement Policies During Declared Emergencies: A Strategic Shift for Diagnostic Developers Read More » FDA’s New Guidance on Computer Software Assurance: A Strategic Shift for Production and Quality Systems Software Read More » New MDCG Draft Guideline on Trend Reporting – What Manufacturers Need to Know Read More » Team-NB – Guidance for Submission of Technical Documentation of IVDs – V2 Read More » European Commission releases final study on the deployment of AI in healthcare Read More » Page1 Page2 Page3 Page4 Page5
TEAM-NB Issues Updated Position Paper on IVDR Annex IX Changes to Companion Diagnostic Devices Read More »
TEAM-NB & NBCG-Med: Call for Evidence on Digital Omnibus – Simplifying AI Regulation with Clarity and Sustainability Read More »
FDA’s New Guidance on IVD Enforcement Policies During Declared Emergencies: A Strategic Shift for Diagnostic Developers Read More »
FDA’s New Guidance on Computer Software Assurance: A Strategic Shift for Production and Quality Systems Software Read More »
