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.

Next dates

Thema	Module	Datum	Zeit	Ort	Preis
Quality Management for Medical Devices according to ISO 13485:2016		04.03.2025 - 05.03.2025	08:00 - 17:00	Winterthur	CHF 1040.-	Anmelden