Clinical Evaluation – Half day course, Online

The course is arranged by Swedish Medtech in co-operation with QAdvis.

The Medical Device Regulation (MDR) emphasises the requirement for sufficient clinical evidence for any device to get CE marked. Clinical data are normally needed for being compliant with the general safety and performance requirements (GSPR) of the regulation.

A clinical evaluation is mandatory for all devices and the main output document, the clinical evaluation report, states whether there is enough clinical evidence to support the clinical safety and performance of the device.

Clinical evaluation is on ongoing procedure to collect, appraise and analyse clinical data of pertinence for the medical device. There is a strong relationship between clinical evaluation, risk management and post-market surveillance.

Topics

• Clinical evaluation – an overview
• Regulatory context
• Clinical data
• Device-specific adaptation
• Equivalence
• Post-market clinical follow-up
• To perform a clinical evaluation – step by step

Prices:

For member companies to Swedish Medtech SEK 3 900:-

For non member companies SEK 5 500:-