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Introduction & Implementation of ISO 13485 Training Course

Face to face Training2 DaysBeginnerVirtual Classroom

We recommend this training if you would like to familiarize yourself with the contents of ISO 13485:2016 and options for its practical implementation. The medical devices standard ISO 13485:2016 has been issued. What are the key changes compared to ISO 13485:2012? What are the requirements for the quality management systems of medical device manufacturers?

At the heart of ISO 13485:2016 is a comprehensive process risk management to be integrated in all medical device-related quality management processes of the company, including outsourced supplier processes. In addition to development and production, this includes processes that take place after medical devices are placed on the market.

Our training will provide you with basic knowledge regarding ISO 13485:2016 and, as part of an implementation workshop, will explain in detail how to integrate the requirements for quality management systems in your company processes.

  • Medical device manufacturer and vendor personnel who will be involved in the launch of management systems or updating of the current management system
  • Quality management officers (QMOs), product managers, Regulatory Affairs personnel
  • Consultants in the medical device industry

  • You will learn how to successfully implement and optimize a QMS based on ISO 13485:2016 in your company.
  • You will benefit from the extensive interpretation of ISO 13485:2016 by our experts.
  • Introduction to the legal and regulatory environment of ISO 13485:2016
  • Legal environment (national and international) and regulatory framework
  • Lifecycle of a medical device
  • Classification of ISO 13485:2016
  • ISO 13485:2016 in detail
  • Process validation and risk analysis, documentation
  • Qualification and infrastructure
  • Development (design control, clinical data, validation)
  • Vendor management
  • Production management
  • Continuous improvement process (CIP): internal errors, complaints, risks
  • Corrective actions, preventive measures
  • Corrective and Preventive Actions (CAPA), reporting process
  • Deepening of the standard section in a practical workshop

  • Course delivered by one of TÜV SÜD's leading industry experts
  • Small class sizes enhance trainer-delegate relationship
  • Receive globally recognised TÜV SÜD certificate upon completion

Upon completion, you will receive your globally recognised TÜV SÜD certificate on Introduction & Implementation of ISO 13485.

Net Price (excl. VAT)
from£ 720.00

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Book training course Introduction & Implementation of ISO 13485 Training Course
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From 09/07/24
Virtual Classroom
£ 720.00 add. VAT

Course No.
1834

Duration
2 Days

Show Agenda

Location
Virtual Classroom

Price

Net Price
£ 720.00
plus VAT:
£ 144.00

Total Price (inc. VAT)
£ 864.00

Course No.
1837

Duration
2 Days

Show Agenda

Location
Virtual Classroom

Price

Net Price
£ 720.00
plus VAT:
£ 144.00

Total Price (inc. VAT)
£ 864.00

Course No.
1839

Duration
2 Days

Show Agenda

Location
Virtual Classroom

Price

Net Price
£ 720.00
plus VAT:
£ 144.00

Total Price (inc. VAT)
£ 864.00