Amended transition timelines of Regulations (EU) 2017/745 and (EU) 2017/746

European Commission to consider extensions to MDR and IVDR deadlines?

Quantification of Benefit – Risk Analysis

The routes to conformity

Clinical Development Plan (CDP)

Identification and Traceability in Medical Device Industry

Verification Versus Validation of Processes in Manufacturing Medical Devices

Overall Residual Risk-How to Evaluate it?

Is your product a LEGACY Certified under IVDD or OLD IVD DEVICE Self-certified under IVDD? Then you have to know this!

Correction Corrective Action and Preventive Action