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United StatesISO 13485 Requirements for Practitioners and Auditors
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).
What makes Comply Guru’s eLearning different from competitors is we instructionally design modules based on engaging, applied learning with real-world examples and case studies. Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
This course is an internationally accredited credential. This course is certified by the Chartered Quality Institute (CQI) and International Registrar of Certificated Auditors (IRCA) under course number 2589. This course is also recognized by the Regulatory Affairs Professionals Society (RAPS) where members will be eligible to receive 8 credits by completing this course.
Overview of our ISO 13485 Requirements Training
What's covered on our ISO 13485 Requirements Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
- Introduction to ISO 13485
- Terms and Definitions
- Plan-Do-Check-Act
- Documentation Requirements
- Process Based QMS
- Risk Based Thinking (RBT)
- Management Commitment
- Related Standards
Case Study! Risk Management
- Establishing a Quality Management System (QMS)
- QMS Documentation
Case Study! Software Validation
Case Study! Record Control
- Management Commitment
& Customer Focus - Quality Policy, Objectives & Planning
- Responsibility, Authority
& Communication - Management Review
Case Study! Management Review
- Provision of Resources
- Infrastructure & Work Environment
Case Study! Training and Document Updates
Case Study! Work Environment and Contamination Control
- Planning
- Customer Related Processes
- Design & Development
Case Study! Customer Related Processes
- Purchasing
- Production & Service
- Control of Monitoring & Measuring
Case Study! Purchasing Controls
- MAI Overview
- Monitoring & Measuring
- Control of Nonconforming Product
- Data Analysis and CAPA
Case Study! Complaint Handling
Case Study! Internal Audits
Michelle Keane
Eoin Philip Kelly
On completion of this course, successful Learners will have the practical knowledge and be able to:
- 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:
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- Quality Managers
- Quality Professionals/Technicians
- Quality Engineers
- Procurement Personnel
- Financial Personnel
- Document Controllers
- Internal Auditors
- Owner Managers
- Implementation Members
Upon successful completion, each Learner shall receive two digital Certificates of Completion.
The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (8).
The first certificate is issued automatically by Comply Guru within 1hr of the course completion that is recognized by the Regulatory Affairs Professionals Society (RAPS).
CQI and IRCA also certify this course (No. 2589) under the course title: FD132: MD-QMS ISO 13485:2016 Foundation Training and Learners shall also receive a second training certificate recognized by CQI and IRCA within 2 business days.
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.
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Frequently Asked Questions
Each license is for 12 months. Upon completion, the module content is still accessible for the full duration. However, the assessments cannot be re-completed once successfully passed (or if you exceed 3 attempts).
Each Learner has a maximum of 3 attempts at each assessment. We strongly encourage all learners to review & revise the course content again before each attempt (if unsuccessful on an attempt).
If unsuccessful after a 3rd attempt, you will not be eligible for certification. No refunds are possible due to a failed examination result.
If you register on the website, you will be able to access the eLearning within 1 hour of registering, subject to successful payment. If you are registering via Purchase Order, access will be enabled within 1 business day of payment being received.
Yes, we offer discounts for 5 or more learners on a scale based on the total number at the time of purchase. If you want to enquire about discounts, request a quote using the form on this page and a member of our team will be in touch.
Once you have successfully completed the training, including all assessments, your certificate will be available within 1 business day. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print from your learner dashboard.
Please note: no certificates are available without full payment on file.
Yes, we permit substitutions provided the license has not been activated and the request is made within 30-days of the purchase date. There is no fee for substitutions.
The eLearning duration provided is based on the average amount of time it takes an average learner who is new to the subject/topic, and has been independently verified by a globally recognized professional body, i.e. CQI and IRCA, RAPS, or Exemplar Global.
In reality, the amount of time it takes to complete the eLearning will vary depending on your prior experience, knowledge & learning style.
Extensions to the eLearning deadline (or license) are reviewed on a case by case basis. If you require an extension, please contact our team outlining your reason for the extension in advance of the expiration. Expired licenses cannot be reactivated or extended.
To complete this course successfully, you will need to fully complete each module and obtain 70% or higher in the applicable assessment(s).
All graded assessments are MCQ-based.
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Training Transformed with Comply Guru
What Our Learners Are Saying
4.5
Average Rating
560 global ratings
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The training was well delivered and clear throughout. The knowledge checks provided a solid chance to confirm the learning at regular stages during the training.
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The course was very interactive and engaging via clicking buttons to get more detail information on each aspect of the course. Moreover, diagram views on most of the sections made easy to understand the topic and its intent.
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Excellent course, builds on the previous knowledge of learners, great use of examples and case studies. Would thoroughly recommend.
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Clear and well structured course with practical examples and useful case studies.
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ISO 13485 Requirements for Practitioners and Auditors has given me a clear understanding of the standard and its practical implications. It also helped me understand its structure and the logic behind it. Overall, I am confident I will be able to use the standard efficiently in my role.
