Mastering the EU Medical Device Regulation and ISO 13485:2016 - An Introductory Training

ENHANCE YOUR SKILLS WITH OUR SPECIALIAZED COURSES

The content of the training covers a general overview of the key points of the EU-MDR and ISO 13485:2016 and serves as an introductory course, as a preview of our advanced training courses on the European requirements for medical devices. An advanced course can be organized to convey further details on one or more specific topics.

DURATION
2X 0.5 days

LANGUAGE
English

WHAT ARE THE OBJECTIVES OF THE MEDICAL DEVICE COURSE?

  • Understanding the impact of the European Medical Device Regulation: Grasping the regulatory changes of the new EU-MDR Review 2017/745
  • Understanding the essential requirements of ISO 13485:2016.

What are the course contents?

European Medical Device Regulation (EU-MDR)

• Grasping the regulatory challenges of the EU-MDR 2017/745
• Learning from experiences on critical processes, especially on risk management according to ISO 14971:2019 and ISO 24971:2020
• Becoming familiar with the content of a technical documentation
• Understanding the key role of the PRRC (Person Responsible for Regulatory Compliance).

 ISO 13485:2016

• Understanding the key requirements of ISO 13485:2016
• Successful implementation or maintenance of a QMS in compliance with ISO 13485:2016
• Simplicity and flexibility for the continuous improvement of the QMS
• Being ready for audits or inspections at all times.

Register now!