Clinical Evidence in Medical Device Conformity Assessment – Basic Course
4611018-EN
Clinical Evidence in Medical Device Conformity Assessment – Basic Course
Instructor-led Training1 day
ENPräsenztraining
Clinical evidence plays a crucial role in the conformity assessment procedure for medical devices. Without sufficient clinical data demonstrating safety, clinical performance, and clinical benefit, obtaining approval in Europe is nearly impossible.
This seminar provides you with the fundamental requirements of European regulations, the MDR, laws, and guidelines for clinical evaluation, and their implementation within the conformity assessment procedure for medical devices. It also covers updates throughout the entire product lifecycle.
Topics include the general process of clinical evaluation and the required contents of key documents such as the Clinical Evaluation Plan and Clinical Evaluation Report. Emphasis is placed on the clinical evaluation requirements from the Medical Device Regulation (2017/745, MDR). The importance of clinical evaluation in the Post-Market Surveillance (PMS) phase, including Post-Market Clinical Follow-up (PMCF), is also discussed.
Importance and types of clinical data for approval and marketing of medical devices
Clinical evaluation requirements under European medical device law
Literature research and review
Process and documentation of clinical evaluation according to MDR and relevant guidelines
Contents and preparation of Clinical Evaluation Plans and Clinical Evaluation Reports
Data identification, assessment, analysis, and developing a clinical strategy to determine the clinical evaluation route
Qualifications of author/reviewer teams
Decision criteria for clinical evaluation routes
Assessment of equivalence to other products
Benefit-risk evaluation
State-of-the-art assessment
Summary report on clinical performance and safety
Interface with risk analysis in evaluating clinical data
Clinical evaluation within the Quality Management system
Weighing the necessity of clinical investigations for conformity assessment procedures
Interface with the Post-Market Surveillance system
Updating clinical evaluations and linking to the PMS system
When are PMCF studies required?
Gain expertise in identifying and providing required clinical data for medical devices.
Successfully perform clinical evaluations of your medical devices.
Implement regulatory requirements and meet official demands regarding clinical evaluation.
Employees in Regulatory Affairs and Quality Assurance
Staff in Research and Development, Clinical Affairs
Employees in Product Management and Marketing
Employees from regulatory authorities
For advanced knowledge, we recommend the follow-up seminar: Clinical Evaluation – Advanced Course (4611079).
This seminar is part of a modular training program. Upon successful completion of advanced modules, you can earn the recognized certification:
Manager Clinical Affairs – TÜV
The seminar covers internationally valid standards and is suitable for international delivery.
The seminar fee includes the professional reference book "Medical Device Regulation (MDR)".
English
Participants receive a certificate of attendance from TÜV SÜD Academy.
This trainingisbeingoperatedby TÜV SÜD Akademie GmbH in Germany. The General Terms and ConditionsaswellasthePrivacy Noticeof TÜV SÜD Akademie GmbH apply. In caseofanyquestions, do not hesitatetocontactus.
