Beschreibung
Introduction to ISO 13485 quality management training course (Englisch)
Ziel
This one day course has been designed to provide an insight into the use of ISO 13485:2016 as the basis for a quality management system implemented by medical device manufacturers.
Time will be spent during the course exploring the requirements of ISO 13485:2016 and how the standard interacts with ISO 9001:2015, the European Medical Device Directive and the US FDA’s Quality System Regulation. In addition to this, participants will also gain an awareness of the relationship between ISO 13485:2016 and ISO 14971, Application of Risk Management to Medical Devices.
Kommende Starttermine
Inhalte / Module
Take the first steps towards ISO 13485:2016 certification
Understand how you can better meet customer and regulatory requirements leading to increased patient safety
Find ways to increase efficiency and cost savings through quality management
Monitor supply chains to achieve continuous improvement
Develop safe and effective medical devices
Motivate employees through CPD.
Nutzen & Mehrwert
On completion of this training, participants will be able to:
Use ISO 13485:2016 as the basis for a QMS for medical device manufacturers
Understand the relationship between ISO 13485:2016 and European Medical Device Directives
Use ISO 13485:2016 as the basis of regulatory requirements worldwide.
Zielgruppe / Voraussetzungen
Senior Management
Quality Managers
Regulatory Affairs Managers
Internal and external - - Auditors
Consultants
Anyone involved with the implementation of the standard
Abschlussqualifikation / Zertifikat
You’ll be awarded an internationally recognized BSI Training Academy certificate.
Infos anfordern
BSI Group Deutschland GmbH
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