PECB/ISO 13485 Lead Implementer

Course Contents

ISO 13485 Lead Implementer Course Overview

ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485.

Target Audience

  • Managers or consultants involved in Medical Devices Quality Management
  • Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
  • Individuals responsible for maintaining conformance with MDQMS requirements
  • MDQMS team members

Learning Objectives

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks 
  • Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization
  • Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices

The 1-on-1 Advantage
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Flexible Dates

  • • Choose Start Date
  • • Reschedule After Booking
  • • Weekend / Evening Option
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4-Hour Sessions

Destination Training
(Dubai/London/Sydney
New York/Delhi/Goa
Singapore)

Flexi
(On Demand Videos)

You will learn:

Introduction to ISO 13485 and initiation of a MDQMS
  • Course objectives and structure
  • Standard and regulatory framework
  • Medical Devices Quality Management System (MDQMS)
  • Fundamental principles of quality and medical devices
  • Initiating the MDQMS implementation
  • Understanding the organization and clarifying the quality objectives
  • Analysis of the existing management system
  • Leadership and approval of the MDQMS project MDQMS scope
  • Quality Policy
  • Definition of the organizational structure
  • Definition of the document management process
  • Design of controls and drafting procedures
  • Communication plan
  • Training and awareness plan
  • Product Realization
  • Operations Management
  • Monitoring, measurement, analysis and evaluation
  • Internal audit
  • Management review
  • Treatment of problems and non-conformities
  • Improvement
  • Preparing for the certification audit
  • Competence and evaluation of implementers
  • Closing the training
  • Exam
Live Online Training (Duration : 40 Hours)
We Offer :
  • 1-on-1 Public - Select your own start date. Other students can be merged.
  • 1-on-1 Private - Select your own start date. You will be the only student in the class.

2050 + If you accept merging of other students.
4 Hours
8 Hours
Week Days
Weekend

Start Time : At any time

12 AM
12 PM

1-On-1 Training is Guaranteed to Run (GTR)
Group Training
1800 Per Participant
Online
03 - 07 Apr 09:00 AM - 05:00 PM CST
(8 Hours/Day)
Online
01 - 05 May 09:00 AM - 05:00 PM CST
(8 Hours/Day)
Can’t Attend Live Online? Click to Buy Flexi For Only $99 (Video Recording of Live Online)
Course Prerequisites

A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.

 

 

 

Student Feedback  (Check Koenig Feedback on Trustpilot)

Q1 Say something about the Trainer? Q2 How is Koenig different from other training Companies? Q3 Will you come back to Koenig for training ?
Student Name Feedback
Abu
United States
A1. Yes, she was very clear & a strong mastery of both English & Azure platforms hence following was easy. She was also patient and was answering every question asked, she also shared material & tips on how to pass the exam, Well done, and keep it up.
Nick Barker
United States
A1. Calm and understanding, she not only kept the course running well but also took time to help those with lots of questions. Very well done.
Robin Johnson
United States
A2. Individual attention during training, excellent customer service and coordination. Neha has been ever so helpful and is definitely an asset to Koenig.
Shivani Prasad
United States
A1. The trainer was great and his teaching methods were incredible. He used different teaching methods to ensure I was learning well. A fun trainer with lots of patience and understanding.
Adam
United States
A1. The trainer was very knowledgeable and well prepared about the presentation/training subject, with a positive attitude towards students and making every effort in answering questions during the training session. Top-notch service!
Suresh
United States
A1. Exceptional... recommend to everyone!
Shyam Vaddakapett
United States
A1. My trainer, Mohit Kakkar was excellent as he focused on hands-on assignments to supplement the concepts of AZ 900. The training coordinator Jasmeet as well as the ops manager Sheshadri are also very professional and customer-centric. I recommend Koenig for training courses, and I will take some more courses with them soon.
Gilles Chirlias
United States
A1. Chavi was a great teacher, I have learned a lot from her. I would like to have her for the next training, which would be the AZ 301 and AZ 500.
Abdulrahman Saad Alshahrani
United States
A1. Excellent trainer. I will take another course with him someday. He deserves a good appreciation from his Manager.
Anonymous
United States
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FAQ's

1-on-1 Public - Select your start date. Other students can be merged.
1-on-1 Private - Select your start date. You will be the only student in the class.
Yes, course requiring practical include hands-on labs.
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The Fee includes:
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Yes, Koenig Solutions is a PECB Learning Partner
Schedule for Group Training is decided by Koenig. Schedule for 1-on-1 is decided by you.
In 1-on-1 you can select your own schedule, other students can be merged but you select the schedule. Choose 1-on-1 if published schedule do not meet your requirement. If you also want a private session, opt for 1-on-1 Public.
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“It is an interesting story and dates back half a century. My father started a manufacturing business in India in the 1960's for import substitute electromechanical components such as microswitches. German and Japanese goods were held in high esteem so he named his company Essen Deinki (Essen is a well known industrial town in Germany and Deinki is Japanese for electric company). His products were very good quality and the fact that they sounded German and Japanese also helped. He did quite well. In 1970s he branched out into electronic products and again looked for a German name. This time he chose Koenig, and Koenig Electronics was born. In 1990s after graduating from college I was looking for a name for my company and Koenig Solutions sounded just right. Initially we had marketed under the brand of Digital Equipment Corporation but DEC went out of business and we switched to the Koenig name. Koenig is difficult to pronounce and marketeers said it is not a good choice for a B2C brand. But it has proven lucky for us.” – Says Rohit Aggarwal (Founder and CEO - Koenig Solutions)
All our trainers are fluent in English . Majority of our customers are from outside India and our trainers speak in a neutral accent which is easily understandable by students from all nationalities. Our money back guarantee also stands for accent of the trainer.
Medical services in India are at par with the world and are a fraction of costs in Europe and USA. A number of our students have scheduled cosmetic, dental and ocular procedures during their stay in India. We can provide advice about this, on request.
Yes, if you send 4 participants, we can offer an exclusive training for them which can be started from Any Date™ suitable for you.