ISO 13485
ISO 13485 Trainings
Quality systems are essential for the manufacture of medical devices and to ensure patient safety. To help your company keep up with regulations, APEX provides training courses in ISO 13485 – a global standard that defines quality management requirements within this industry. ISO 13485 certification ensures your business meets certain legal and quality management system standards that allow you to become more competitive in the medical device industry and improve your internal processes.
This course is offered in cooperation with DEKRA SERVICES, an Exemplar Global Certified Provider or PROBITAS Authentication Certified course provider.
With relevant insight tailored towards understanding and applying these important standards, APEX Consulting allows you to create a dependable framework of proven quality system practices that guarantee superior operating efficiency throughout any organization involved with medical devices.
We offer the following three ISO 13485 certification courses:
- ISO 13485:2016 Foundations Training
- ISO 13485:2016 Internal Auditor Training
- ISO 13485:2016 Lead Auditor Training
Which ISO 13485 Course is Right for Me?
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Lead Auditor
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Internal Auditor
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Foundations
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Content
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Course objectives geared towards those who are planning to manage audit teams and lead an audit program
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Course objectives geared towards those who are planning on scheduling internal audit programs for medical devices
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Course objectives geared towards those who are seeking an introduction to medical devices
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Work Sessions
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18 Activities
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16 Activities
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12 Activities
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Timed Exam
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1.5 hours
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2 hours
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2 hours
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Participant Criteria
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Participation
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Verbal Communication
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Written Reports
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Achieve Objectives for Course
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Content | Course objectives geared towards those who are planning to manage audit teams and lead an audit program |
Work Sessions | 18 Activities |
Timed Exam | 1.5 hours |
Participant Criteria | Participation Verbal Communication Written Reports Achieve Objectives for Course |
Content | Course objectives geared towards those who are planning on scheduling internal audit programs for quality medical devices |
Work Sessions | 16 Activities |
Timed Exam | 2 hours |
Participant Criteria | Participation Verbal Communication Written Reports Achieve Objectives for Course |
Content | Course objectives geared towards those who are seeking an introduction to medical devices |
Work Sessions | 12 Activities |
Timed Exam | 2 hours |
Participant Criteria | Participation Verbal Communication Written Reports Achieve Objectives for Course |
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.
We offer both in-person and virtual learning options, and the two-day ISO 13485 training class concludes with a written competency exam.
Course Details
Length: 2 days
Hours: 8:00am-6:00pm
CTUs: 1.6
Competency Unit: MD
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
Online Sessions 💻 – $1095
In-Person Sessions 👨🏫 – $1195
Highlighted Topics
Major requirements of the ISO 13485:2016 standard
Types of evidence needed to demonstrate conformity to ISO 13485:2016
Relevant terminology for medical device quality management systems
The relationship between ISO 13485 and applicable regulatory requirements
Learning 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
Course Format
Certified by Exemplar Global
Learn to plan and schedule an internal audit program for medical device quality management systems
Develop the skills you need to conduct a successful audit in this course devoted to the ISO 13485:2016 Medical Device Quality Management System standard. This three-day class begins with foundational knowledge of the ISO 13485 standard and builds upon it to prepare you for real-life auditing situations—including managing the audit process and completing reporting—via hands-on workshops and two competency exams (MD & AU).
Course Details
Length: 3 days (M-W)
Hours: 8:00am-6:00pm
CTUs: 2.4
Competency Units: MD, AU
Audience: Anyone responsible for planning and scheduling an internal audit program for ISO 13485:2016, including quality assurance managers, ISO project managers, ISO project team members, compliance managers, and regulatory personnel
Online Sessions 💻 – $1395
In-Person Sessions 👨🏫 – $1495
Highlighted Topics
Requirements of the ISO 13485:2016 standard
Terminology for medical device quality management systems
Principles, processes, and methods of auditing
The Plan-Do-Check-Act (PDCA) methodology
Learning Objectives
Fully understand and successfully interpret the ISO 13485 requirements
Identify medical device QMS terms
Understand how to audit using the process approach
Ask audit questions that get results
Describe the relationship between ISO 13485:2016 and applicable regulatory requirements
Prerequisites
Course Format
Certified by Exemplar Global
Learn how to lead an audit program for medical device quality management systems
Develop the skills you need to lead a successful medical device audit in this ISO 13485 lead auditor training course. Specifically designed to meet the needs of the medical device industry, this four-day class prepares medical device lead auditors for real-life situations via hands-on workshops.
Participants will learn how to lead the audit process and to complete reporting. Three competency exams are included that can be submitted to Exemplar Global as part of your application for ISO 13485 Lead Auditor certification.
Course Details
Length: 4 days (M-Th)
Hours: 8:00am-6:00pm
CTUs: 3.6
Competency Units: QM, AU, TL
Audience: Anyone responsible for leading an audit program for ISO 13485, including quality assurance managers, quality assurance professionals, ISO project managers, ISO project team members, compliance managers, or regulatory personnel
Online Sessions 💻 – $1895
In-Person Sessions 👨🏫 – $2095
Highlighted Topics
Requirements of ISO 13485, ISO 9001, and 21 CFR 820
How to apply the standards in the medical device sector
Methods for planning and conducting an audit
Audit skills and behaviors necessary for an effective, efficient management system audit
Learning Objectives
Fully understand and interpret the requirements of ISO 13485
Understand 21 CFR 820 requirements and be able to compare these to ISO 13485 requirements
Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
Understand how to apply ISO 9001 and ISO 13485 standards during in-class practical audit exercises
Understand terminology of ISO 9001 and ISO 13485 and application in a medical device environment
Understand terminology of ISO 9001 and ISO 13485 and application in a medical device environment
Develop an ISO 9001/ISO 13485 auditing system based on the ISO 19011 auditing requirements
Learn how to ask audit questions that get results and to construct effective audit checklists
Learn how to conduct opening and closing meetings that have impact
Learn how to generate effective corrective actions
Prerequisites
Course Format
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