FREE ON-DEMAND WEBINAR
Clinical Evaluations and Clinical Investigations for Medical Devices under MDR
Are you involved in the development or evaluation of medical devices? Do you want to enhance your understanding of the Clinical Evaluation and Clinical Investigation processes? Look no further and watch our Clinical Evaluation and Investigations Training, designed to provide you with comprehensive knowledge and practical insights into this critical aspect of medical device assessment.
- Medical Devices
Description
Clinical Investigations are systematic investigations involving one ore more human subjects undertaken to assess the safety or performance of a device. Following topics are covered in the Webinar:
- The different phases of a Medical device
- Why investigations are being performed
- Which stages exist and their turn around times.
Clinical Evaluation is the assessment and analysis of clinical data of a medical device to verify its clinical safety and performance as part of conforming with the general safety and performance requirements set out in Annex I of the MDR. The Clinical Evaluation process will be explained by the following topics:
- MDR requirements for Clinical Evaluation
- The Clinical Evaluation Process
- Sources of Clinical Data
Speaker
Anke Van Roost
Anke Van Roost is a Project Manager at QbD Clinical, specializing in clinical research. With 6 years of experience in both pharmaceutical and medical device industries, Anke has served as a Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), and Project Manager (PM). At QbD Clinical, Anke efficiently manages various internal studies, overseeing the entire process from beginning to end. Her expertise and dedication ensure smooth execution and successful outcomes for clinical projects.
Pia Gyselen
Pia Gyselen is the Head of Medical Writing at QbD Clinical. With an impressive 25-year tenure in clinical research, spanning both pharmaceutical and medical device industries, Pia brings a wealth of expertise to her role. Her extensive experience includes 15 years in project management and 10 years in medical information and writing. Currently, Pia oversees the Medical Writing department at QbD Clinical, where she leads a team of 4 talented medical writers. With Pia’s guidance and wealth of knowledge, the Medical Writing department excels in delivering high-quality, accurate, and impactful documentation.