Onsite Training
Auditing Clinical Aspects of EU-MDR
What Manufacturers and other Economic Operators should know
![](https://www.akrateam.com/wp-content/uploads/2023/12/Visual_ClinicalAudit_1223_02-1024x536.jpg)
Description
Recommended training for the preparation of Notified Body audits
With the Medical Device Regulation (MDR) published in 2017 many new requirements were introduced that 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 device. Thus, the MDR enhances the expectation on a compliant systematic approach to collect and evaluate clinical data throughout the device lifecycle in pre- and post-market phases. Included are expectations for a systematic and active post market surveillance (PMS) and post market clinical follow up (PMCF) System. Several MDCG documents provide additional information on the interpretation and implementation of the obligations to perform clinical evaluations for innovative, equivalent, and legacy devices to ensure clinical evidence for clinical claims on safety and performance. Specifics how to plan, conduct, and document clinical investigations, PMCF studies and manage the reporting to Notified Bodies (NB) and Competent Authorities (CA) are aspects that contribute to a high level of transparency and scrutiny. The role of the European Database for Medical Devices (EUDAMED) or alternative solutions need to be understood to ensure the reporting obligations and communication with EU Commission, EU Pannels, CA, NB and Public. All provision defined in MDR and related regulatory framework need to be mirrored in the manufacturers Quality Management System. Auditing all relevant clinical aspects of the MDR are an expected integral part of the internal audit program of the Manufacturer.
Hotel recommendation for onsite trainings:
Arthotel ANA Goggl, Hubert-von-Herkomer-Straße 19, 86899 Landsberg am Lech, Phone: +49 8191 3240
Net price
on demand
- 2 days onsite training
- Workshop and experience exchange
- Presentation slides
- Participation certificates
- MDCG documents
- Catering: Coffee breaks and lunch incl.
Overview of covered topics
- Clinical Aspects of MDR and related regulatory framework
- Embedding Clinical Aspects of EU-MDR in the Quality Management System
- Interlink regulatory MDR requirements with ISO 13485 and ISO 14155
- Understand the approach to audit clinical aspects for MDR readiness
Purpose of the training
The participants shall be enabled to:
- Identify and understand the clinical aspects of MDR and related regulatory framework
- Navigate the interlinks of several MDCG documents and MDR Articles and Annexes
- Embedding Clinical Aspects of MDR in the Quality Management System
- Understand the relation of regulatory MDR requirements with ISO 13485 and ISO 14155
- Consider the approach to audit clinical aspects for MDR readiness
Who should attend
- Regulatory Team of Manufacturer
- PRRC
- Quality Team and Auditors of Manufacturer
- Clinical Team of Manufacturer
- Authorized Representative
- Medical Device Service Provider e.g., CRO, Medical Writer, Clinical Evaluator
- Other
Basic knowledge required
- Basic knowledge in EU-MDR
Presenting experts
Our trainers have long-time experience working with one of the biggest notified bodies and in clinical research and regulatory consulting.
![](https://www.akrateam.com/wp-content/uploads/2023/07/Susanne.png)
Dr. Susanne Gerbl-Rieger
Senior Consultant
AKRA TEAM GmbH
![](https://www.akrateam.com/wp-content/uploads/2023/06/Markus.png)
Prof. Dr. Markus Balkenhol
Team Leader - Senior Clinical Consultant
AKRA TEAM GmbH
markus.balkenhol@akrateam.com
![](https://www.akrateam.com/wp-content/uploads/2023/06/Anna.png)
Dr. Anna Spehl
Senior Consultant
AKRA TEAM GmbH
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