Sustaining an MDR (Medical Device Regulation) compliant QMS through continuous audit readiness
Successful participants in this training will:
- Acquire audit requirements according to MDR in a compact way.
- Gain knowledge of new elements in the audit context based on the MDR.
- Get a profound overview of the changes that arise in the audit due to the MDR.
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
This training is intended for the following target group:
- Manufacturers and operators of medical devices
- Managers and professionals from the medical device industry who work as auditors
- Internal auditors, quality management representatives
- Product managers, project managers, regulatory affairs officers
- EU officials, surveillance authorities
- Audit processes according to MDR
- General safety and performance requirements
- Overview of contents of technical documentation
- Classification overview, labeling
- Influence on the quality management system
- Common specifications and standards
- Risk management, vigilance and reporting
- Economic operators post-market surveillance
- Special features of remote audits
In the course of the final implementation of the Medical Device Regulation (MDR 2017/745) on May 26, 2021, this law has become mandatory for all manufacturers of medical devices, and hence also the respective audit processes ever since have been in the focus of notified bodies and medical device manufacturers.
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
Participants will receive a Certificate of Attendance by TUV SUD Academy.
Knowledge of the MDR, ISO 13485:2016, and auditing is desirable.