Medical device manufacturers and sponsors need to understand and comply with the current Quality Management System (QMS) standard requirements of ISO 13485:2016. 

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

Ultrasound medical device

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 four (4) key areas of ISO 13485.  It will cover:

  1. The Regulatory Environment
  2. The ISO model for an effective process-based QMS
  3. The application and integration of a Quality Risk Management (QRM) framework
  4. Key areas of ISO 13485 (including 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 businesses that supply to ISO 13485 regulated companies.  Business types that have benefited from ISO 13485 training include:

  • Medical device design and manufacturing groups
  • Medical device sponsors whose products are manufactured in other 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 course will be delivered as an online virtual-classroom training session.

Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.

The training will be delivered as 2 full day sessions. Breaks are included.

PDF Certificates will be provided to participants electronically.

What Do I Need?

Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.

Sessions

Each participant will attend both full-day sessions:

 Sessions  Dates  Times
 Day 1  15th September 2021  8:45am join for 9:00am-5:00pm
 Day 2  16th September 2021  8:45am join for 9:00am-5:00pm

Times are based on Melbourne, Australian Eastern Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00.

Participants to join at 8:45am in advance of a 9:00am to address any technical issues.

Fee and Discount
  • AUD $1,200 (exc. GST) per participant
    • A 10% discount applies for 3 or more participants from the same company

This September session has been cancelled.

If you're Australian and interested in ISO 13485 training, please click here to learn about the upcoming ISO 13485 workshops supported by the REDI initiative, powered by MTPConnect 

Contact us to discuss your interest in a  public or private delivery of this course.

Refer to the Terms and Conditions

Martina Hayes Circle Gradient Grey BG 182x182

Proposed Trainer

Martina Hayes

Martina is a graduate of the Cork Institute of Technology, Ireland, with an honours degree in Biomedical Engineering. Upon completing her degree, she secured a place at Stryker’s highly competitive Rotational Graduate Programme in the Quality Stream, where she rotated through all aspects of the Quality Management System. From there, she transitioned into a Senior role as a Manufacturing Engineer within Stryker. Moving to Sydney, Martina held various Regulatory and Quality roles with Australian medical device companies. Martina is currently completing a Master’s in Medical Technology Regulatory Affairs and has recently completed further trainings including:
  • BSI ISO 14971:2019 Medical Devices Risk Management
  • BSI ISO 13485:2016 QMS Lead Auditor Training Course CQI & IRCA certified
  • BSI ISO 13485:2016 Clause by Clause