Clinical Assessment Training

All medical devices new or old that are introduced to the market within the borders of the European Union must have an up-to-date Clinical Assessment Report as part of their Technical File. Contradiction in terms continues in the industry with respect to basic requirements and best practices relating to the composition and updating of these reports. With the introduction of the New Medical Device Directive (AB) 2017/745; review of clinical assessment reports with respect to new requirements, gap analysis and proper planning and provision of supportive clinical data before the process for certification under MDR have become important. 

Purpose of the Training 
The training has been designed for you to understand the clinical assessment process including the legal requirements relating to the clinical assessment, clinical assessment principles and details as to how these are carried out and certified. Practical activities included in the scope of the training gives you the opportunity to implement your skills to carry out a clinical assessment in your firm following the completion of the training.  

Who should participate?

• Clinical Experts 
• Licensing Experts
• Medical Device R&D Engineers
• Medical Device Producers 
• Internal and External Auditors 
• Quality Managers
• Development, Production and Marketing Managers 
• Medical Secretaries 

Content of the Training 

• What is clinical assessment?
• Qualifications of Staff Carrying Out the Clinical Assessment Process 
• Changes under MDR 
• SSCP 
• Clinical Research Requirements 
• Clinical Consultation Processes 
• Definitions in Clinical Assessment Processes 
• Clinical Data Sources 
• Equivalence Requirements 
• Assessment of Clinical Data 
• Analysis of Clinical Data 
• Clinical Assessment Report 
• Risk/Benefit Analysis ve Assessment of Total Residual Risk 
• Clinical Assessment Update 
• Sufficient Clinical Data 
• Overview of the Clinical Work In Medical Devices 
• Practical Activities 
• Training Event Questions 

Benefits of the Training 

• Ability to define the clinical assessment process changes in the scope of MDR 
• Ability to determine the basic requirements in the clinical assessment processes according to the MDR, MEDDEV 2.7/1 Revision 4 and related MDCG guides 
• Ability to explain the principles of clinical assessment 
• Ability to outline the stages of clinical assessment stages and documentation requirements 
• Ability to explain the equivalence concept 
• Ability to determine when a clinical research is required for a medical device  Ability to define the requirements of a clinical assessment report

References 
MDR, MDCG Guides, Meddev 2.7/1 Rev 4