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 Duration 14 hours

Course Outline

Introduction

ISO 13485 Overview

  • The objective and scope of ISO 13485
  • The significance of ISO 13485 within the medical device industry
  • Essential terminology and definitions

ISO 13485 Architecture and Clauses

  • Comprehending the structure (Annex SL)
  • Summary of principal clauses: 4 through 8

Quality Management Principles

  • The process approach and the PDCA (Plan-Do-Check-Act) cycle
  • Application of risk-based thinking to medical devices
  • The critical role of customer focus and regulatory obligations

Core Requirements of ISO 13485:2016

  • Detailed analysis of clauses 4 through 8
  • Controls for design and development
  • Risk management across the product lifecycle
  • Management of documents and records

Implementing and Maintaining an ISO 13485 QMS

  • Procedure for establishing an ISO 13485-compliant QMS
  • Staff training and competency standards
  • Process monitoring and measurement

Audit and Certification Procedures

  • Overview of internal and external auditing
  • Preparation for certification: key expectations
  • Addressing non-conformities and implementing corrective actions

Conclusion and Future Directions

Requirements

  • Familiarity with fundamental quality management concepts

Target Audience

  • Quality Managers
  • Quality Engineers
  • Auditors and Regulatory Compliance Personnel

Custom Corporate Training

Training solutions designed exclusively for businesses.

  • Customized Content: We adapt the syllabus and practical exercises to the real goals and needs of your project.
  • Flexible Schedule: Dates and times adapted to your team's agenda.
  • Format: Online (live), In-company (at your offices), or Hybrid.
Investment

Price per private group, online live training, starting from 2600 € + VAT*

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