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 provide the necessary skills to ensure all the requirements of the law are met and provide an insight into how clinical evaluation is integrated with risk management, post-market surveillance, the periodic safety update report, the summary of safety and clinical performance, trending and the CAPA system.

Content includes

LEARNING OBJECTIVES
- Understand the additional requirements for clinical evaluation imposed by the MDR 2017/745
- Know how to address continuous updates of a clinical evaluation report in a practical way
- Understand where clinical evaluation fits in the legal framework
- Gain effective techniques for establishing that sufficient Information is presented in a CER
- Gain a solid understanding of what your QMS needs to cover.

Day 1
- What is Clinical Evaluation?
- Definitions and Key Terminology
- Clinical Evaluation and the MDR
- What has changed under the MDR?
- Post Market Clinical Follow-up (PMCF)
- Guidance for Clinical Evaluation
- Links to other processes

Day 2
- Clinical Data Evaluation
- Clinical Evaluation Plan
- Plan Objectives
- Sources of Data & Claims ERs/GSPRs
- Literature Search & Databases
- State of the Art

Day 3
- Getting your questions right
- Clinical Evaluation Competencies
- Identification of Data
- Appraisal & Analysis
- Risk of Bias
- Meta Analysis

Day 4
- Clinical Evaluation Report
- Clinical Investigation
- Ethics & Consent
- Best Practice
- The NB 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: