Medical Device Regulation (MDR) – Requirements for Quality Management Systems
In this training course,
- The legal requirements of the Medical Device Regulation (MDR) are conveyed to participants in a compact manner in order to implement them in their QM system.
- You will get an overview of how to constantly update and continuously improve your QM system in accordance with the MDR.
- You will gain knowledge of new elements in the QM system based on 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].
Who Should Attend?
- Manager Regulatory Affairs
- Quality Management Officer, Head of Research & Development, Safety Officer/PRRC and Managing Director in Medical Technology Companies
- Importers, distributors and medical device consultants
- EU authorised representatives and staff in supervisory authorities
- Suppliers and other service providers in the field of medical technology
Course Agenda
- Regulatory foundations in Medical Device Regulation (MDR)
- Impact on economic operators
- Who needs a quality management system?
- Necessary contents of a quality management system compliant with the MDR
- Impact on QMS compared to ISO 13485:2016
- Need for updates and changes
- Need to update the quality management system
- Changes in the quality management system
- New elements in the QMS
- Scope, liability aspects, responsible person, registration of products and economic operators, labelling and instructions for use, advertising material, information, implantation card
- Summary Report on Safety and Clinical Performance (SSCP), PMS Plan and Report/PSUR, Economic Operators and Their Obligations in PMS, Post-Market Surveillance, Unique Device Identifier – UDI, EUDAMED
- Practical implementation
Course Description
The European Medical Device Regulation (MDR, 2017/745) has been in force since 2017. Every manufacturer of medical devices from Class I to III is legally obliged to establish, document, apply, maintain, constantly update and continuously improve a quality management system. The MDR requirements also apply to economic operators involved, such as EU authorised representatives, suppliers and importers. The requirements of the MDR go well beyond the contents of the current standards ISO 13485:2016 or ISO 9001:2015. This seminar teaches you the regulatory basics and necessary content from the MDR for quality management systems. We will show you the need to update existing systems and provide you with the necessary knowledge so that you can upgrade your QM system for the MDR. In our one-day seminar, you will acquire a compact overview in order to set up new and necessary elements in accordance with the MDR in the quality management system.
Benefits
Manufacturing medical devices in compliance with quality management.
Methodology
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.
Learning Assessments
Certificate of participation from the TÜV SÜD Academy.
Course Material
Please bring a copy of the MDR with you to the course. A free copy can be downloaded from the EUR-Lex European Union law website.
Prerequisites
In-depth knowledge of MDR and ISO 13485:2016.