ISO 13485:2016 Introduction - International

Niveau Comprendre Durée 1 journée de formation

Disponible pour réserver: Salle de classe virtuelle 1010€ + TVA Book your place

This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001 and the European MDR/IVDR. The relationship with ISO 14971 ‘Application of Risk Management to Medical Devices’ is also explored during the course.

Please note that this training will be held in English!

Pedagogical objectives

This course will help you:

Take the first steps towards ISO 13485:2016 certification
Understand how you can better meet 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

On completion, you will be able to:
- Explain the use of ISO 13485:2016, as the basis for a quality management system for medical device organizations
- Define the overall structure of ISO 13485:2016
- Apply the process approach concept of the standard
- Recognize the key clauses of the ISO 13485:2016 standard
Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
Course materials including:
- Introduction to the training, detailed program and security assignments
- Course presentation, theory and activities/roles plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
- Course materials, provided electronically
- Letter of attestation
- Official certificate
* These training modules are eligible to the subsidizing by the public institutions in France (OPCO).

**Each delegate receives a training convention after enrollment.

***Please note that for the public sessions, you have until 48h before the start of the course to confirm your enrollment. For the in-house sessions, the deadline would be of two weeks prior to the start of the course.

****Should you be in a disabled situation, please contact us and indicate what details should be taken into account.

You can contact us on training.france@bsigroup.com or 01 89 79 00 40.

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