The ISO 13485 Lead Implementer Training – E-learning course is tailored for those seeking an awareness of ISO 13485 and its requirements. The course provides a comprehensive overview of the ISO 13485:2016 standard, its benefits, requirements, documented information, certification steps, the ISO 13485 Implementer Verification Checklist, and more. This online ISO 13485 training is suitable for employees of all organizations, students, professionals, and individuals who aim to gain a complete understanding of the ISO 13485:2016 international standard. The course also offers useful reference sample documents such as ISO 13485 manual, sample method, Hazard risk identification sheet, aspect-impact identification filled sheet, and other resources. Upon successful course completion, participants will have gained a full understanding and awareness of ISO 13485:2016 implementation.
TOPICS COVERED UNDER ONLINE ISO 13485 LEAD IMPLEMENTER TRAINING COURSE
This ISO 13485 Lead Implementer Training online course is divided into three sections:
- Session 1: Overview of ISO 13485:2016
- Session 2: ISO 13485:2016 Principles
- Session 3: ISO 13485:2016 Requirements
- Session 4: Control of Documents and Records
- Session 5: Risk Management
- Session 6: Steps for ISO 13485:2016 QMS Installation & Certification
Video Tutorials:
Expert-led video tutorials are provided for all six sessions, accessible on the course dashboard. Participants can watch these videos, which come with Play / Resume / Repeat features, at their own pace until the course is completed. For certain sessions like documentation, risk, and steps, animated videos are also provided to help lead implementers share knowledge further with their employees or clients.
Handouts:
Handouts for all listed sessions, totaling more than 200 pages in PDF format, are provided. Participants of this ISO 13485 Lead Implementer Training can save and print the handouts, or read them offline, to gain a comprehensive understanding of the covered topics. In addition to these six topics, participants will receive other sample documents to use as ready referral materials.
Exams:
The course includes a total of six session exams and one final exam. After successfully passing all exams, participants can download and print their ISO 13485:2016 Lead Implementer Training certificate.
COURSE OBJECTIVES
Upon completion of the ISO 13485 Lead Implementer Training, participants will be able to:
- Gain an overview and awareness of ISO 13485:2016
- Familiarize themselves with ISO 13485:2016 Quality Management System of Medical Devices
- Understand the Plan-Do-Check-Act Cycle of ISO 13485 requirements
- Gain a detailed understanding of ISO 13485:2016 requirements and sub-clauses
- Understand, maintain, and retain documented information lists
- Familiarize themselves with ISO 13485 certification steps
WHO SHOULD ATTEND ISO 13485 LEAD IMPLEMENTER TRAINING?
This ISO 13485:2016 Lead Implementer Training course is designed for working professionals, college students, and other individuals aiming to enhance their careers. The e-learning course helps them excel in today’s competitive environment, renew licenses, and update, strengthen, and add quality to their existing knowledge and skills. It’s also valuable for those seeking certification or starting a new profession.
If you are a working professional, student, entrepreneur, or individual looking for certified ISO 13485 Lead Implementer Training, you can Enroll Now!
AUTHORS & INSTRUCTORS
For details about the authors, trainers, and instructors’ experience and background, please visit our trainers page. They possess extensive experience in the subject.
STUDY MATERIALS
This e-Learning course provides study materials that can be accessed after logging in or downloaded in PDF format. Use these materials to reinforce key points and keep a reminder of what you’ve learned. You can save them on your computer for future reference. Access to these study materials is removed after successfully clearing the exam and preparing the online certificate for the student.
EXAMINATION AND COURSE CERTIFICATE
All paid E-learning courses include a Course Certificate issued upon course completion and passing the session exams as well as a final exam given in the course with a minimum score of 60%. Students who do not pass an exam have the option to retake it.
END OF COURSE INSTRUCTION
After completing the sessions and passing each session’s examination, students can proceed to the final exam. Successful completion of the final exam marks the end of the course. The training certificate is available on our LMS for printing or saving, and it can be verified using the name and certificate number.
