Online Training
Clinical Evaluation and Clinical Evidence for Medical Devices
What Subject Matter Experts & Manufacturers should know
Available Dates & Times
● 1. Oct. 2024:   14:00-18:00 h CET      |     8:00am-12:00pm US EST
● 8. Oct. 2024:   09:00-13:00 h CET
Language
English/Deutsch
based on preference of participants
Description
With the European Medical Device Regulation (EU-MDR) published in 2017, enhanced and new requirements were introduced. Among others, these relate to the systematic collection, evaluation, reporting of clinical data and the continuous demonstration of clinical evidence for safety, performance, and an acceptable benefit /risk ratio of a medical device.
The limitation on equivalent approaches and the expectations on the conduct of clinical investigations and proactive PMCF activities play a crucial role for the demonstration of compliance to relevant General Safety and Performance Requirements (GSPRs). Thus, the EU-MDR increases the expectation on a compliant systematic approach and methods for clinical evaluation throughout the device lifecycle in pre- and post-market phases.
Clinical Evidence is required to specifically demonstrate compliance with at least GSPRs 1 and 8 when drawing-up the Clinical Evaluation Report (CER). The responsibility to provide sufficient clinical evidence lies with the manufacturer.
The training aims at providing a sound understanding of clinical evaluation and the framework to identify sufficient clinical evidence throughout the lifecycle of a device.
Net price
€ 330.00
- Access to online training
- Presentation slides as handout
- Participation certificates
Overview of covered topics
- Regulatory Framework for Clinical Evaluation
- Clinical Data and Clinical Evidence
- Clinical Evaluations and Clinical Investigations
- Clinical Evaluation throughout Medical Device Lifecycle
- Real World Evidence
- How Clinical Evidence links to Risk Management, Biocompatibility, PMS
Purpose of the training
Participants will be enabled to
- Navigate through the EU-MDR, MDCG and other guidance documents
- Understand the concept on clinical data and clinical evidence
- Implement a step-by-step approach for clinical evaluation
- Consider decision criteria for the conduct of clinical investigations
- Recognize methods to collect clinical data throughout the MD lifecycle
- Contribute to compliant process descriptions for clinical evaluation
Who should attend
- Manufacturer
- Clinical Affairs Manager
- Regulatory Affairs Manager
- Medical Writers
- Clinical Affairs Experts
- PMS-Manager
- Personal, directly or indirectly involved in the clinical evaluation process
Basic knowledge required
- Basic knowledge in EU-MDR
- Basics in Clinical Evaluation
- Basics Risk Management
- Basics in Post Marketing Activities and PMCF
Presenting experts
Our trainers have long-time experience working with one of the biggest notified bodies and in clinical research and regulatory consulting.
Dr. Susanne Gerbl-Rieger
Senior Consultant
AKRA TEAM GmbH
Prof. Dr. Markus Balkenhol
Team Leader - Senior Clinical Consultant
AKRA TEAM GmbH
markus.balkenhol@akrateam.com
Dr. Anna Spehl
Senior Consultant
AKRA TEAM GmbH
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