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

Those who want to understand the requirements of ISO 13485:2016, those responsible for planning and scheduling an internal audit program for ISO 13485:2016, and those who must perform audits to ISO 13485:2016 – manufacturing, suppliers, managers, or anyone interested in conducting first-party, second- party, or third-party audits.

Course Objectives

• Describe the ISO 13485 Medical Device Quality Management System (QMS) Requirements for Regulatory Purposes standard and development process

• Identify medical device QMS terms

• Describe the intent and requirements of ISO 13485:2016

• Determine the evidence needed to demonstrate conformity to ISO 13485:2016

• Apply the process approach and Plan-Do-Check-Act (PDCA) methodology

• Describe the relationship between ISO 13485:2016 and applicable regulatory requirements

Training Time: 16 hours

 

Continuing Education Credits (CEUs): 1.6

Our Virtual Live Training classes are conducted through an online platform by one of our subject matter experts in one or more sessions.

Understand the requirements of ISO 13485:2016 and the evidence to demonstrate conformance. Learn how it compares to 21 CFR 820 and ISO 9001:2015. Led by our experienced trainers, the courses include hands-on workshops in an engaging and collaborative learning environment.

• Exemplar Global Competency Unit MD
• Identify medical device QMS terms
• Describe the intent and requirements of ISO 13485:2016
• Determine the evidence needed to demonstrate conformity to ISO 13485:2016
• Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
• Describe the relationship between ISO 13485:2016 and applicable regulatory requirements.

The instructor-led, virtual course is delivered in 6 convenient, 4-hour sessions spread over 2 weeks. There is an online exam for each competency unit to be completed within 3 days of completing each unit to receive the documentation required for full certification.

System Requirements

• Operating System: Windows 7 and up; or MAC OS X 10.13 and up;
• High-speed internet connection (2.5 Mbps download, 3.0 Mbps upload)
• Speakerphone or computer audio (VOIP). A telephone headset is recommended for optimal audio quality
• Webcam is required to take an online proctored exam.
• Fully understand and successfully interpret the ISO 13485 requirements
• Understand how to audit using the process approach
• Ask audit questions that get results

Training Time: 16 hours 

Continuing Education Credits (CEUs): 1.6

The virtual classes are certified by Exemplar Global and qualify for early registration and multiple attendee discounts Early 30-day Registration Discount $100 applied when registration is processed. 

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.