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ISO 13485 Requirements for Practitioners and Auditors Training is for anyone looking to gain a comprehensive understanding of the core requirements of ISO 13485 and this highly interactive course can be completed anytime, anywhere (24/7).
Our online training is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
Course Structure Explained
eLearning Module Breakdown & Timings
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
| Time | Topic |
|---|---|
| 70mins eLearning | Module 1 – Overview of ISO 13485
Case Study! Risk Management |
| 110mins eLearning | Module 2 – Establishing a Quality Management System
Case Study! Software Validation Case Study! Record Control |
| 65mins eLearning | Module 3 – Management Responsibility
Case Study! Management Review |
| 80mins eLearning | Module 4 – Resource Management
Case Study! Training and Document Updates Case Study! Work Environment and Contamination Control |
| 95mins eLearning | Module 5 – Product Realization, Part 1
Case Study! Customer Related Processes |
| 70mins eLearning | Module 6 – Product Realization, Part 2
Case Study! Purchasing Controls |
| 70mins eLearning | Module 7 – Measurement, Analysis, and Improvement
Case Study! Complaint Handling Case Study! Internal Audits |
| 45mins | Certification Exam
|
Course Overview
ISO 13485 Requirements Training
Explain the purpose of a medical device quality management system, of medical device quality management systems standards, and the business benefits of improved performance given by an effectively implemented medical device quality management system
Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF individual country regulatory documents
Explain the specific quality management-related requirements of ISO 13485
This course is targeted at:
-
- Quality Managers
- Quality Professionals/Technicians
- Quality Engineers
- Procurement Personnel
- Financial Personnel
- Document Controllers
- Internal Auditors
- Owner Managers
- Implementation Members
CQI & IRCA certify this course (No. 2327). Upon successful completion, each Learner shall receive a digital Certificate of Completion within 1 business day.
It is recommended that each Learner should have the following prior knowledge before completing this course:
- The Plan, Do, Check, Act (PDCA) cycle
- The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
- The fundamental concepts and commonly used quality management terms and definitions
Fluency in written and spoken English
- For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.
Copy of ISO 13485 (International Standard)
- It is recommended that each Learner should have a copy of ISO 13485:2016 (International Standard) to reference while completing this course. This is not provided by Comply Guru and without it, this course will be challenging to complete successfully.
In order to successfully complete this course, each Learner will need to:
- Complete the course modules and obtain 70% or higher in the final assessment (MCQ-based)
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.5
Average Rating
508 global ratings
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Very good course by way of introduction to the ISO standard and it was easy to follow & in logical order. One thing you might look at is providing greater detail on critical areas with a few examples possibly by way of more case studies, as there were a couple of these.
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It was a great experience
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Good training experience and right amount of challenging in sense of assessments and final assessment.
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8/10
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The e-learning course content was really good, very well aligned with the layout of IS013485 which made it very easy to follow and it was well presented and informative
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