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ISO 13485:2016 Foundations
In this course you will learn to Identify medical device QMS terms, describe the intent and requirements of ISO 13485:2016, and determine the evidence needed to demonstrate conformity to ISO 13485:2016.
Course Delivery: In-Person Training, Virtual Live Training, Training for Teams
This course has multiple delivery options to fit our customers’ individual needs. Click the tabs below for more information on each option.
In-Person Training
Virtual Live Training
Training for Teams
In-Person Training
In-Person Training consists of public classes conducted by one of our subject matter experts at one of our designated locations in one or more consecutive days.
Target Audience
Anyone seeking to understand the requirements of an ISO 13485 Medical Device QMS, including quality assurance professionals, ISO project managers, compliance managers, and regulatory personnel.
Course Objectives
- Describe the ISO 13485:2016 QMS standard and its development
- Identify medical device QMS terms
- Describe the intent and requirements of ISO 13485
- Determine the evidence needed to demonstrate conformity to ISO 13485
- Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
- Describe the relationship between ISO 13485:2016 and applicable regulatory requirements
Prerequisites
All attendees are required to bring their own copy of the standard ISO 13485:2016 Quality Management – Requirements For Regulatory Purposes. Copies will not be provided for you.
Benefits
Establish a working knowledge of regulatory requirements needed to develop and produce medical devices. Gain an in-depth understanding of the ISO 13485:2016 Medical Device Quality Management System standard when you enroll in this instructor-led course. Designed for anyone seeking to learn about quality management requirements for designing, developing, and producing medical devices, this ISO 13485 course distills essential information about the medical device quality management system.
Agenda
This is a two-day, instructor-led course. The training will cover ISO 13485:2016 as a standard, with a corresponding competency exam.
Training Time: 16 hours
Continuing Education Credits (CEUs): 1.6
Virtual Live Training
Our Virtual Live Training classes are conducted through an online platform by one of our subject matter experts in one or more sessions.
Target Audience
Anyone seeking to understand the requirements of an ISO 13485 Medical Device QMS, including quality assurance professionals, ISO project managers, compliance managers, and regulatory personnel.
Course Objectives
- Describe the ISO 13485:2016 QMS standard and its development
- Identify medical device QMS terms
- Describe the intent and requirements of ISO 13485
- Determine the evidence needed to demonstrate conformity to ISO 13485
- Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
- Describe the relationship between ISO 13485:2016 and applicable regulatory requirements
Prerequisites
All attendees are required to bring their own copy of the standard ISO 13485:2016 Quality Management – Requirements For Regulatory Purposes. Copies will not be provided for you.
Benefits
Establish a working knowledge of regulatory requirements needed to develop and produce medical devices. Gain an in-depth understanding of the ISO 13485:2016 Medical Device Quality Management System standard when you enroll in this instructor-led course. Designed for anyone seeking to learn about quality management requirements for designing, developing, and producing medical devices, this ISO 13485 course distills essential information about the medical device quality management system.
Agenda
This is a two-day, instructor-led course. The training will cover ISO 13485:2016 as a standard, with a corresponding competency exam.
Training Time: 16 hours
Continuing Education Credits (CEUs): 1.6
Training for Teams
Training for Teams provides training for your group of employees in either a virtual live setting, or in-person at your facility. Connect with us to customize any of our standard courses to fit your specific need.
Currently scheduled classes are shown below. If no classes are displayed, please contact QCTS for other options.
