Course Description:

Course "The ISO 13485 Quality Management System" has been pre-approved by RAPS as eligible for up to 6 credits towards a participant's RAC recertification upon full completion.

ISO 13485 is the international standard for a Quality Management System (QMS) for medical device manufacturers. Many geographic regions, including the European Union and Canada, require ISO 13485 as the Quality Management System (QMS) for device manufacturers who market their products in that region, regardless of the manufacturing location in the world. In addition, many regions, such as the European Union, add additional requirements.

Understanding ISO 13485 is important for device manufacturers to build an effective and compliant system. The workshop takes you through the regulatory requirements and explains how to implement them. The workshop provides guidance on the regulatory requirements and explains how they support medical device design and manufacture.

In addition, the workshop explains the history of ISO 13485 and its relationship to ISO 9001. We look at specific regional differences, such as the European Union’s EN ISO 13485:2012. ISO 13485 has a guidance document, ISO/TR 14969, which provides valuable information on applying ISO 13485.

Areas Covered:

The workshop covers the following areas:

  • The history of ISO 13485
  • Versions of ISO 13485 in the EU and Canada
  • Quality management system and documentation
  • Management responsibility
    • Quality policy and objectives
    • Quality planning
    • Management review
  • Resource management
    • Human resources
    • Infrastructure
  • Product realization
    • Planning
    • Design
    • Production
    • Purchasing
    • Monitoring and measuring devices
  • Improvement
    • Internal quality audits
    • Corrective action and preventive action

Who will Benefit:

This seminar is valuable to anybody involved in medical device manufacturing for markets outside the US . The employees who will benefit include:

  • Research and development
  • Production
  • Regulatory affairs
  • Quality assurance
  • Quality control
  • Senior and executive management

Course Outline:

Schedule (QSR Seminar)
9:00 AM - 10:30 AM
  • The history of ISO 13485
  • Versions of ISO 13485 in the EU and Canada
  • Quality management system and documentation
  • Management responsibility
10:30 AM - 10:40 AM
  • Break
10:40 AM - 12:00 Noon
  • Resource management
12:00 Noon - 1:00 PM
  • Lunch
1:00 PM - 2:30 PM
  • Product realization
2:30 PM - 2:40 PM
  • Break
2:40 PM - 4:00 PM
  • Improvement

Meet Your Instructor

Dan O'Leary
President at Ombu Enterprises, LLC

Dan O'Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.

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Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $100 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

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What past attendees say:

With the simple approach take by Dan, anyone can learn how to complete a successful MDD implementation.
- Quality Specialist, Rochester Medica

Dan OLeary displayed complete and total Mastery of the subject in this presentation, and in his answers to the questions asked from him.
- Quality Manager, Parker Hannifin Corp

I enjoyed Dan's course very much. The Instructor and materials were excellent and the information he taught will be very helpful to my Company.
- Compliance Coordinator, Diagnostica Stago, Inc.

The MDD subject matter was well illustrated by Den by flow chart and graphics. Please keep offering this subject matter.
- Senior Quality Assurance Engineer, NDI Medical LLC

I have attended webinars from ComplianceOnline but this "Live" one was incredible. This seminar was excellent.
- Quality Engineering Manager, ConvaTec Inc.

I like the medical device directive and topic regarding standards. The design of the presentations was appropriate.
- Director of Research and Development, Metrex Research,LLC

It was well organized event by ComplianceOnline. Communication was good. Presenter was very knowledgeable. Practical application of directives, standards, regulations are very helpful.
- Manager, Quality Assurance, Instrumentation Laboratory

It was well organized event by ComplianceOnline with good subject matter and knowledgeable instructor.
- Director of Operations and Quality, NDI Medical LLC

I appreciate the knowledge given at this seminar. Speaker is very experienced and I found good talent here. I am very happy with first class reference sheet.
- Sr. CAPA Specialist, Johnson & Johnson Vision Care Inc

Knowledgeable speaker with great real life examples and discussions.
- Quality Director, Lifecore Biomedical

It was a well organized seminar. It provides trainees a good understanding about the CA-PA process that complies with regulatory standards.
- QA/RA Representative, ResMed Corp

It was my first conference with ComplianceOnline and experience was good. Love the reference material and flash key.
- Quality Assurance, Beckman Coulter

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  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.


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