News 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 » New EC survey reveals slow progress in MDR and IVDR certifications Read More » MedTech Europe proposes a more proportionate approach to sampling under the IVDR Read More » Notified Bodies publish key recommendations for the future governance of EU medical devices Read More » EU Survey Highlights Certification Bottlenecks Under MDR and IVDR Read More » Page1 Page2 Page3 Page4 Page5
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 »
Notified Bodies publish key recommendations for the future governance of EU medical devices Read More »