Medical Devices – ISO 13485 & ISO 14971
Manufacturers of Class II, III and IV medical devices in Canada must establish and maintain a certified ISO 13485 Quality Management System in order to comply with Health Canada requirements and obtain and Medical Device Establishment License.
The BRC offers a full range of quality management training and related services for medical device manufacturers, suppliers and distributors…
ISO 13485:2016 Training Courses
Transitioning to ISO 13485:2016
This 1-day course provides in-depth study of the new ISO 13485:2016 standard for medical device quality management systems.
- Learn the new requirements through hands-on exercises and class discussion.
- Critical knowledge for leadership, management and team members who need to understand the new requirements of ISO 13485:2016 as they prepare to transition the organization’s QMS.
Intended for those who are already familiar with ISO 13485:2003 and who want to focus on the changes found in the 2016 edition.
Understanding & Implementing ISO 13485:2016
This introductory course provides a broad understanding of the requirements of ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes. Through immersive, hands-on exercises and discussion, participants will review the standard’s requirements in detail and review approaches and techniques for implementing its requirements.
This 2-day course is intended for those who have little to no experience with previous editions of the ISO 13485 standard, or who need a broader understanding with more in-depth discussion.
ISO 13485:2016 Internal Auditor
Building on knowledge acquired through previous training in the requirements of ISO 13485:2016, this course delivers the practical knowledge required to conduct internal audits of an ISO 13485:2016 Quality Management System.
A review of ISO 13485:2016 to ensure thorough and common understanding of the new requirements is followed by information on how to conduct audits in accordance with the ISO 9000 series of standards:
- ISO 19011:2011 – “Guidelines for Auditing Management Systems”, and
- “Guidance on the Concept and Use of the Process Approach for Management Systems”.
Through a balance of formal presentations, case studies, simulation of audit activities and group activities, participants will learn the necessary elements to perform a quality audit.
ISO 13485:2003 Training Courses
Understanding & Implementing ISO 13485:2003
This introductory course will give students a broad understanding of the ISO 13485:2003 Quality Management System requirements for implementation of the 2003 standard.
Through a balance of formal presentations, case studies, simulation of audit activities and group activities, participants will:
- Interpret all clauses of ISO 13485:2003.
- Understand the essential requirements of ISO 13485:2003.
- Understand the proper use of ISO 14969 (guidance for implementation of an ISO 13485 quality management system.
- Understand the methodology of implementing such a system.
- Understand the essentials of ISO 14971 (The Medical Device Risk Management Standard).
- Recognize the role of management in implementing and maintaining ISO 13485.
ISO 13485:2003 Internal Auditor
Building on knowledge acquired through previous training in the requirements of ISO 13485:2003, this course delivers the practical knowledge required to conduct internal audits of an ISO 13485:2003 QMS.
A review of ISO 13485:2003 to ensure thorough and common understanding of the new requirements is followed by information on how to conduct audits in accordance with ISO 19011:2011 – “Guidelines for Auditing Management Systems”.
Through a balance of formal presentations, case studies, simulation of audit activities and group activities, participants will learn the necessary elements to perform a quality audit.
ISO 14971 (Risk Management) Courses
Understanding ISO 14971:2007 (Risk Management)
This course is designed to provide participants with an understanding of ISO 14971:2007 – Risk Management for Medical Devices.
Participants will discuss the general principles of risk management, review the requirements of ISO 14971:2007, walk through the steps involved in the risk management process, and review the tools provided in the Annexes of the 14971 standard.
Exercises are designed to place you in the mindset necessary for risk analysis and management.
Understanding ISO 14971:2007 & Title 21 CFR Part 820
This course is designed to provide participants with an understanding of ISO 14971:2007 – Risk Management for Medical Devices, as well as the impact that the FDA’s CFR 820 has on the decision-making process at medical device manufacturing firms.
This 1-day training course helps medical device professionals gain an understanding of how CFR 820 will affect their processes and procedures to ensure compliance to the US FDA. Participants will also understand how CFR 820 applies to ISO 13485:2003.
