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ISO 13485 Medical Devices Foundation

ISO 13485 Medical Devices Foundation

This one day course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directive and the US FDA’s Quality System Regulation.

ISO 13485:2016 Medical Devices
Level: Foundation
Course duration: 1 Day

Classroom Based
*Minimum of 4 delegates for In-House Training

Who is it for?

  • Senior Management
  • Quality Managers
  • Regulatory Affairs Managers
  • Internal and external Auditors
  • Consultants

Indicative Course Content

History of ISO 13485:2016

Introduction to ISO 13485:2016 & Structure , including the relationship with ISO 9001:2015.

Overview of  ISO 13485:2016 requirements

Interested Parties , Documented requirements

Clause 4 Quality management system – The risk-based approach

Clause 5 Management Responsibility – clarification of requirements, planning, responsibility and authority, management representation and management review.

Clause 6 Resource management

Clause 7 Product realization

Clause 8 Measurement, analysis and improvement

Short Test

Reflection & feedback