The Benefits of Creating an ISO 13485 Based QMS for HTM Professionals

Upcoming Courses


This course aims to demystify ISO 13485, the process-based quality management system structure that focuses on risk reduction, customer satisfaction, and continuous improvement. It provides participants with a practical guide to the requirements of ISO 13485, offering step-by-step guidance, tools, and examples for implementation. Additionally, the course provides valuable insights into Norton's QMS implementation story, sharing real-life experiences, challenges faced, and successful strategies employed by Norton's Clinical Engineering group.


By the end of this course, participants will gain a clear understanding of ISO 13485 sections, learn how to practically apply its requirements, and benefit from the knowledge and experiences shared by Norton Healthcare's successful QMS implementation story.

What to expect

Over the course of twelve (12) hours, the learner will be able to:
    Understand the standards of ISO 13485 in everyday language and comprehend the relevant requirements for achieving ISO certification.
    Analyze and apply hands-on tools to conduct an ISO 13485 readiness gap analysis for their organization.
    Utilize templates provided to create the necessary quality system procedures, forms, and records required for ISO accreditation.
    Recall practical lessons shared by the ISO quality leader from Norton Healthcare, a renowned pioneer in ISO 13485 accreditation for in-house medical device servicing.

Who Should Attend?

HTM Professionals, Hospital Regulatory Professionals, and Hospital Executives with administrative oversight of Clinical/Biomedical Engineering departments.

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email


Mark Cooksey

DME Quality Engineer, Norton Healthcare

DME Quality Engineer, Norton Healthcare 
Six Sigma Black Belt 
Steering Committee Member, Medical Devices Servicing Community