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Business Industry Medical Device Development

ISO 13485:2016 QMS - Lead Auditor Preparation Exam

ISO 13485 Practice Exam | Validate QMS Standard knowledge, Medical Devices Regulatory Framework | Audit Case Studies
Rating: 3.4 out of 53.4 (21 ratings)
83 students
Created by Waqas Imam
Last updated 3/2020
English
30-Day Money-Back Guarantee

Included in This Course

92 questions

  • Practice Test 1 - Audit Case Studies2 questions
  • Practice Test 2 - MCQ Based (Fill in the Blank and True/False)30 questions
  • Practice Test 3 - MCQ Based (Fill in the Blank and True/False)30 questions
  • Practice Test 4 - MCQ Based (Fill in the Blank and True/False)30 questions

Description

ISO 13485:2016 standard is made on the quality philosophy of Plan, do, check and Act Cycle. The standard is based on regulatory frameworks like FDA 21 CFR Part 820 and ISO 9001:2008. Organizations have to check themselves whether their operations are done according to plan phase or not. Similarly if you are a quality professional and ISO 13485 beginner, or expert you also have to check your expertise in Quality Management System. This "knowledge validation exam" helps you to check and validate your knowledge on ISO 13485:2016 standard and its fundamental concepts like importance of regulatory compliance, medical device file, product recall and advisory notices etc.

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Value Addition Alerts:

  1. Passing Certification Awarded By Instructor

  2. Road Map for Further Learning

Certification: Udemy does not provide certification for exams, they only do in the case of Video Courses. But the great news here is, we have empowered our paid students to have a certificate, once they qualify by 80% in the exams. It is a manual process, in which learners our requested to submit evidence of qualification, and apply for the certificate. The certificates are issued at the end of a month.

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Exam Composition

You will be assessed when you take this online exam in following areas (Course Objectives):

  • The publication of new ISO 13485 standard

  • The specific differences between ISO 13485:2016 and the older versions

  • PDCA Approach

  • Regulatory Compliance

  • Medical Device Files

  • Design and Development Process

  • Product Recall and Complaints

  • Internal Auditing

  • ISO 13485:2016 interpretation in companies

  • Improvement

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Food for Thought

Be Familiar with ISO 13485:2016 knowledge which you hold...

If you think you are an expert in ISO 13485 after taking courses on the subject and working with ISO 13485...

You need to hold on!

Join this exam and self assess yourself!

Maybe you need to learn and learn...

Or you can prove your knowledge and expertise by successfully completing this exam.

Both ways, you are in a win-win situation.

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Note: ISO 13485 standard is a copyright document of ISO. We will not be sharing the standard. Please purchase it from ISO store.

Good news: We will be adding more content for example case studies to practice tests in the future. If you feel that you lack the knowledge you can take ISO 13485 courses from Udemy or the instructor to guide you on gaining ISO 13485 knowledge.

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One Month Money Back Guarantee: Don't forget One Month 100% Money Back Guarantee without inquiry. This means you have unconditionally no risk when registering to this Course.

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Ask Questions & Report Complaints: Discussion forum on the right side of this course can be used to discuss specific queries and report problems you are facing about the content of the course.

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Take this course: Follow the “Take This Course" Button by clicking at the Top Right Hand Side of the Page. Proceed with the instructions and follow it to register and pay for the course.

Who this course is for:

  • Quality Professionals curious about ISO 13485 & looking to assess knowledge
  • Corporate Personals looking to appear in ISO 13485:2016 Lead Auditor training
  • Any one who is looking to earn ISO 13485:2016 IRCA CQI Lead Auditor Certificate
  • Individuals who failed first attempt of ISO 13485:2016 Lead Auditor Exam
  • Professionals who plan to undertake 5 days IRCA certified Lead Auditor Course
  • Quality Professionals who work on ISO 13485:2016 Quality Management System

Instructor

Waqas Imam
Industrial Engineer| IRCA Auditor|Medical Devices Expert
Waqas Imam
  • 3.8 Instructor Rating
  • 730 Reviews
  • 5,555 Students
  • 7 Courses

S. M. Waqas Imam is an Industrial Engineer by qualification and has served in the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor.

He had also served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA.

He also served as expert Blog writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.

Recently he is associated with Medical Device Community as Ambassador. He also writes compliance articles on Surgical Units.

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