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Quality Management for Medical Devices according to ISO 13485:2016

Basics Seminars Quality Management for Medical Devices according to ISO 13485:2016

Deepen your understanding of quality management in the medical device industry and acquire the necessary skills to implement an effective Quality Management System (QMS) according to ISO 13485:2016. This seminar provides you with a detailed insight into the specific requirements of ISO 13485:2016, preparing you to enhance the quality and safety of your medical devices, minimize risks, and meet regulatory requirements. Discover how to develop a QMS that not only ensures compliance but also boosts efficiency and customer satisfaction.

Seminar Contents:

Introduction to ISO 13485:2016: Understand the scope, objectives, and main requirements of the standard.
Structure and Key Elements of a QMS for Medical Devices: Learn the key elements of an effective QMS, including management responsibility, resource management, product realization, and continuous improvement.
Risk Management: Deepen your understanding of risk management within the framework of ISO 13485:2016 and learn how to systematically identify, assess, and control risks.
Regulatory Requirements: Gain an overview of regulatory requirements in various markets and how ISO 13485 supports meeting these requirements.
Documentation and Records: Learn how to effectively manage the required documentation and keep records to ensure compliance and transparency.
Internal Audits and Management Reviews: Learn how to plan and conduct internal audits and effectively use management reviews to evaluate and improve the effectiveness of your QMS.
Continuous Improvement: Discover strategies and tools for the continuous improvement of your QMS and enhancing product quality.

Target Audience

This seminar is ideal for::

  • Quality managers and professionals in the medical device industry
  • Staff responsible for implementing and maintaining a QMS
  • Regulatory Affairs Managers and staff dealing with regulatory requirements for medical devices
  • Executives and decision-makers in medical device companies

Your Benefits

  • Expertise: Gain in-depth knowledge about ISO 13485:2016 and its application in practice.
  • Compliance: Meet regulatory requirements and enhance the quality and safety of your medical devices.
  • Efficiency: Optimize your processes and increase the efficiency of your QMS.
  • Networking: Exchange ideas with industry experts and colleagues and expand your professional network.

Learning methodology

  • Exchange & teaching discussions with the participants as well as the experts
  • Implementation of practical workshops based on case studies or directly on the example of one’s own company for an optimal knowledge and competence transfer to one’s own organization
  • Exchange & reflection of practical experiences of the participants and experts in comparison to the theory
  • Additional learning units to complement the contact lessons (literature study, forum discussions, sample assignments, etc.)

Course Duration

2 days / 16 hours 

Costs

Seminar Costs: CHF 1040.- 

Register now to deepen your expertise in quality management for medical devices and make a significant contribution to quality assurance and compliance in your company!

Please be aware that the seminar is currently only available in German.