ISO 13485:2016

Dates: To be verified.

Duration: 1 day

Location: 7 Centre Court, Blyry Business and Commercial Park, Athlone

Accreditation: Certificate of attendance

Full Fee: €395 including course manual, lunch and refreshments.

Programme overview

The ISO 13485 standard “Quality Management Systems. Requirements for regulatory purposes” is used globally by medical device manufacturers as a regulatory pathway to bring their medical devices onto some of largest worlds markets – Europe, Australia, Japan, Canada, South Korea and Brazil, etc.
This standard provides the quality system architecture to demonstrate their compliance to strict regulatory requirements in these regions

Some of the key changes to ISO 13485:2016 include:

  • Inclusion of risk management across all process activities
  • Additional requirements for design activities
  • Additional requirements for process validation and verification activities
  • Improvement in supplier control processes using a risk-based approach
  • Increased emphasis on feedback methodologies
  • Explicit requirements for quality system software
  • For outsourced processes control based on risk and ability to meet specifications and requirements
  • Detailed requirements in Technical file
  • Management Review frequency determination

Learning outcomes

  • Understand regulatory requirements around ISO13485:2016
  • Understand key changes from 2003/2012

Who is the course for

  • Validation Engineers
  • Quality EngineersPersonnel planning ISO13485:2016 introduction

This course is designed for Senior Management, Quality Managers, Quality Engineers, QA and Regulatory personnel working on QMS’s in industry.


Course Content

  • Module 1. Background and History
  • Module 2. Quality Management System
  • Module 3. Management Responsibility
  • Module 4. Resource Management
  • Module 5. Product Realization
  • Module 6. Improvement
  • Module 7. Risk-Based Management

Trainer Profile

TP Lowry has over thirty years in medical device and pharma industries working as Analyst, Engineer, Quality Manager to Operations Director. Consultant for the past sixteen years

MBA , Doctor of Quality Management

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