ISO 13485:2016 Lead Implementer Training

The ISO 13485 Lead Implementer Training are for professionals who aspire to become lead implementers for medical device quality management system. Participants in the ISO 13485 lead implementer course also receive ISO 13485 lead implementer certification.

DETAILS

The ISO 13485 lead Implementer E-learning course is specifically designed for those who want to get an awareness of ISO 13485 and its requirements. The course includes in detail an overview of the ISO 13485:2016 standard, the benefits of ISO 13485, the standard requirements, a list of documented information, steps for certification, the ISO 13485 Implementer Verification Checklist, etc. This ISO 13485 training online course is helpful for employees of all types of organizations, students, professionals, and individuals to get complete awareness of ISO 13485:2016 international standard. This online ISO 13485 lead implementer training course also provides useful ready referral sample documents like ISO 13485 manual, sample method, Hazard risk identification sheet, aspect-impact identification filled sheet, and other resources. Upon successful completion of this course, the participants will gain complete knowledge and awareness of ISO 13485:2016 implementation process.

TOPICS COVERED UNDER THE ISO 13485 LEAD IMPLEMENTER TRAINING COURSE

This ISO 13485 lead implementer training online course comprises three sections, as given below:

1. Session 1: Overview of ISO 13485:2016
2. Session 2: ISO 13485:2016 Principles
3. Session 3: ISO 13485:2016 Requirements
4. Session 4: Control of Documents and Records
5. Session 5: Risk Management
6. Session 6: Steps for ISO 13485:2016 QMS Installation & Certification

1. Video Tutorials
   For all of above-listed six sessions, the video tutorials by experts are provided to watch on course dashboard. Participants of this course can watch them with features Play / Resume / Repeat anytime till they completed the course. For some of sessions like documentation, risk and steps, we have provided animated videos also that help lead implementer to share knowledge further to their employees or clients.
2. Handouts
   For all the above-listed sessions, handouts in more than 200 pages are given in pdf format. The participant of this ISO 13485 lead implementer training can save the handouts in their computer and print it or read it offline to get detailed knowledge of all the six topics listed above. Other than above six topics, participant will get other sample documents to use as ready referral material as listed below.
   1. Quality Manual for Medical Device
   2. Procedures
      • Procedure for Management Review
      • Procedure for Document and Data Control
   3. Process Flow Chart
      • Process Flow for Training Activity
   4. Sample Forms
      • Format for Change Note
      • Format for Purchase Order (Outsourcing)
      • Format for Employee Wise Training & Competence Record Sheet
   5. Sample Risk Analysis sheet
   6. Sample Management Review Meeting
3. Exams
   In this course, a total of six session-exams and one final exam is given. After passing all the exams, the participants can download and print their ISO 13485:2016 lead implementer training certificate.

COURSE OBJECTIVES

Upon completion of the ISO 13485 lead implementer participants will be able to:

• Get an overview of ISO 13485:2016 and its awareness also.
• Familiarize yourself with ISO 13485:2016 Quality Management System of Medical Devices.
• Understand the Plan-Do-Check-Act Cycle of ISO 13485 requirements.
• Get a detailed understanding of the ISO 13485:2016 requirements and sub-clauses.
• Understand, maintain, and retain documented information lists.
• Familiarize yourself 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 for enhancing their career to new heights. Our e-learning courses help them to succeed in today’s competitive environment, to renew licenses, and to update, strengthen and add quality to their existing knowledge and skills. Our courses are also useful for those who want to get a certification or start a new profession.

If you are a working professional, or a student, an entrepreneur, or an individual looking for certified ISO 13485 lead implementer training, you can Enrol Now!

STUDY MATERIALS

This e-Learning course is provided with study materials and you can read it after your log in or download (PDF format). Use the study materials to reinforce key points and to keep a reminder of what you already learned as well as you can save it in your computer for future reference. The access of this study material is removed after exam is cleared and on line certificate is prepared for the student.

EXAMINATION AND COURSE CERTIFICATE

All paid E-learning course includes the Course Certificate that is issued upon course completion and passing the session exams as well as a final exam given in the course with minimum 60% marks. The option to reappear in the exam is also given to student, if failed in any exam.

END OF COURSE INSTRUCTION

After completing the session and passing each session examination the student can appear for final exam. Once the final exam is cleared then it is considered a end of course. The training certificate is ready on our LMS and student can print it or save the training certificate. It is also available for verification by entering the name and certificate number.