Quality Training

Clinical Evaluation for Medical Devices Training

Objectives

The Irish Medtech Skillnet is delighted to join MEDDEV Solutions in bringing you this exciting programme which will help you to understand and equip you with the knowledge, skills, and expertise required to conduct rigorous and compliant clinical evaluations of medical devices. Throughout this training, MEDDEV Solutions review the core principles and practices that underpin effective clinical evaluations, while addressing the latest regulatory requirements, real world examples and best practice in the field.

Content includes

LEARNING OBJECTIVES
-Appreciate the clinical evaluation requirements for all classes of medical device
-Explain how equivalence works
-Identify when clinical data is and is not required
-Select safety and performance outcome parameters
-Link QMS processes such as risk management and PMS with clinical evaluation
-Define what state of the art is and how it is used
-Apply systematic methods to gather and appraise data
-Construct your CER to ensure it passes notified body scrutiny
-Apply best practices

Day 1
- What is Clinical Evaluation?
- Definitions and Key Terminology
- Clinical Evaluation process.
- Clinical Evaluation and and the MDR
- Equivalence
- Links to other processes

Day 2
- Clinical Evaluation Plan
- Plan Objectives
- Data Sources
- Claims
- GSPRs
- State of the Art

Day 3
- Safety and Performance outcome parameters
- Literature Search and Databases
- Develop and Question -PICO
- Identification of Data
- Appraisal & Analysis
- Risk of Bias

Day 4
- Clinical Evaluation Report
- Determining sufficient evidence
- Post Market Clinical Follow-up (PMCF)
- Summary of safety and clinical performance (SSCP)
- Clinical evaluation guidance
- Best Practices
- Notified Body Perspective

This course is recommended for anyone involved in implementing or maintaining a clinical evaluation file.
- Quality Engineers
- Quality Managers
- Regulatory Professionals
- Clinical Data Evaluators
- Clinical Sponsors

Upcoming dates: