As a medical device manufacturer or sponsor you will need to understand and comply with the current Quality Management System (QMS) standard >> ISO 13485:2016. 

This 2-day training course will provide you with the knowledge, skills and tools to implement a new or update your current QMS in compliance with the current ISO 13485:2016 standard. 

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At the end of this course you will be able to:

  • Know your legal obligations as a sponsor or manufacturer
  • Understand the success factors for an effective QMS, and the benefits it delivers
  • Develop risk management strategies for products and processes
  • Determine if your organisation is ISO 13485 audit-ready
  • Develop plans to streamline your QMS and maintain practical compliance

Content

The course will provide a short introduction to the regulatory landscape of Quality for medical device companies followed by practical advice to help you implement a QMS across the following four (4) key business areas of ISO 13485.  It will cover:

  1. The Regulatory Environment
  2. The ISO model for an effective process-based Quality Management System (QMS)
  3. The application and integration of a Quality Risk Management (QRM) framework
  4. Key areas of ISO 13485 and changes in the 2016 standard
    • Management responsibility
    • Resource management
    • Product realisation
    • Measurement, analysis and improvement

Participants

This course will assist organisations preparing for ISO 13485 certification (or re-certification to the 2016 standard).  It will also be of interest to suppliers to ISO 13485 regulated companies.  SeerPharma have already received interest in this course from a range of businesses such as:

  • Medical device design and manufacturing groups
  • Medical device sponsors whose products are manufactured in low-cost regions and then distributed in Australia and Europe
  • Pathology companies
  • Suppliers to medical device companies looking to gain a competitive edge

Format and Course Length: 

The 2-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.

Contact us and register your interest in a public session or having this course delivered on-site.

Refer to the Terms and Conditions