Clinical Evaluation for Market Approval

Manufacturers planning to market their devices in Europe are required to provide clinical data in line with the European Medical Device Regulation

This intensely comprehensive course on Clinical Evaluation for Market Approval will empower you with the essential information, requirements and guidelines you need to successfully and accurately conduct clinical evaluation either as part of the compliance with the EU MDR or as part of the planning of prospective clinical investigations anywhere in the world. From regulatory process and compliance to literature review and conformity; get on the right track to market approval today.

Part 1: EU-MDR Clinical Evaluation Process 
The first installment provides professionals with an expert overview of the EU regulations and how they can positively impact global market access as well as a detailed outline of the necessary steps to follow to achieve immediate and lasting compliance of their clinical evaluation process.

Part 2: Clinical Evaluation Plan and Literature Review Process
Formulate a plan as a basis of the clinical evaluation process. Learn how to establish safety and performance claims, and accurate considerations of standard of care as well as derive meaningful information from the risk assessment, form an important basis for the clinical evaluation plan. Effectively prepare and conduct a literature review according to the MEDDEV 2.7.1 guidelines and EU MDR requirements; You will learn how to generate valid clinical evidence to enhance device acceptance in routine medical practice as well as within the EU regulatory framework.

Part 3: Clinical Evaluation Analysis and Report
In the final course you will learn the steps for producing the clinical evaluation report - including substantiating device claims, standard of care as well as clinical data analysis, critical discussion and conclusion to determine conformity for CE marking, plan post market surveillance activities or designing clinical investigations.