ISO 13485:2016 - Introduction and Implementation

• Medical device manufacturer and supplier’s personnel who will be involved in the launch of management systems or updating of the current management system
• Quality management officers (QMOs), product managers, regulatory affairs managers
• Consultants in the medical device industry

• Introduction to the legal and normative environment of ISO 13485:2016
  • Legal environment (national and international) and regulatory framework
  • Lifecycle of a medical device
  • Classification of ISO 13485:2016
• ISO 13485:2016 in detail
  • Process validation and risk analysis, documentation
  • Qualification and infrastructure
  • Development (design control, clinical data, validation)
  • Supplier management
  • Production control
  • Continuous improvement process (CIP): internal errors, complaints, risks
  • Corrective and Preventive Actions (CAPA), reporting process
• Workshop: deepen the knowledge about the chapters of ISO 13485:2016

The international standard ISO 13485:2016 forms the basis for an effective quality management system in the medical device industry and its suppliers. We recommend you join this seminar if you would like to familiarize yourself with the contents of ISO 13485:2016 and options for its practical implementation.

What are the requirements for the quality management systems of medical device manufacturers? At the heart of ISO 13485:2016 is a comprehensive process risk management to be integrated in all medical device-related quality management processes of the company, including outsourced supplier processes. Beside development and production of a medical device, processes have to be taken into account after the medical device have been placed on the market.

Our two-day seminar will provide you with basic theoretical knowledge regarding ISO 13485:2016 and the implementation workshop, will explain in detail how to integrate practically the requirements for a quality management system into your company's processes.

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This online instructor-led 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.