Quality Management Systems for Medical Device Manufacturers Regarding ISO 13485
This course is certified by Exemplar Global.
This training course helps to understand the requirements of ISO 13485:2016 and to derive the sensible implementation in your company.
After successful completion of the training, you will:
- Know what you have to pay attention to when introducing or adapting the management system and know the success factors.
- Acquire the necessary knowledge how to install a quality management system as a manufacturer of medical devices or as a supplier in the medical device industry.
This course is ideal for experts and executive personnel of medical device manufacturers and their suppliers that are involved in quality management system introduction, establishment and maintenance in the area of medical devices.
Professionals in the medical device industry who want to gain a basic understanding of management systems and regulatory requirements.
Basics of implementation of management systems for manufacturers of medical devices
- Overview of the current status of standardization
- Application and validity of ISO 13485:2016
- Link to international regulatory requirements
- Structure and content of ISO 13485:2016
- Key implementation aspects
- Documentation requirements
- Differences between ISO 9001:2015
One of the challenges in implementing an effective quality management system for medical devices is to effectively transfer the requirements of applicable standards to your own company. ISO 13485:2016 has a process-oriented structure and requires a process-oriented view of the company during implementation of a quality management system.
During the training, you will discuss a selection of main topics of ISO 13485:2016, including risk management, change management, software validation, extended requirements for development and market surveillance of medical devices, which will be more strongly weighted in Europe in the future.
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As a professional, it's important to have recognition for your skills and knowledge. Exemplar Global Accreditation provides this recognition, giving you a competitive edge in the marketplace. With over 30 years of experience building certification programs, Exemplar Global is the leading authority in accreditation for the conformity community.
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- Access to Exemplar LINK
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- One self-coaching assessment
- Extended learning content
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- The chance to look into alternatives for employment and career advancement
- A TÜV SÜD / Exemplar Global Graduate Certificate
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This seminar addresses internationally valid standards. The contents of the seminar correspond to the current status of the revision/harmonization.
- Instructor-led in a virtual classroom
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognised TÜV SÜD certificate upon completion
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.