Master ISO 13485 with Our Comprehensive Lead Implementer Course

Course Contents

ISO 13485 Lead Implementer Course Overview

The ISO 13485 Lead Implementer certification signifies a professional's ability to implement and maintain a Medical Device Quality Management System (MD-QMS) as per ISO 13485 standards. It demonstrates expertise in various regulatory requirements, risk management, and auditing techniques within the medical devices industry. Industries use this certification as a benchmark to hire competent professionals to ensure their systems meet global standards and regulatory requirements, ultimately optimizing quality management and efficiency. It is particularly crucial for industries involved in the design, production, and servicing of medical devices to meet patient safety and customer satisfaction objectives.


The 1-on-1 Advantage

Get 1-on-1 session with our expert trainers at a date & time of your convenience.

Flexible Dates

Start your session at a date of your choice-weekend & evening slots included, and reschedule if necessary.

4-Hour Sessions

Training never been so convenient- attend training sessions 4-hour long for easy learning.

Destination Training

Attend trainings at some of the most loved cities such as Dubai, London, Delhi(India), Goa, Singapore, New York and Sydney.

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
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.

2400 + If you accept merging of other students. Per Participant & excluding VAT/GST
4 Hours
8 Hours
Week Days

Start Time : At any time

12 AM
12 PM

1-On-1 Training is Guaranteed to Run (GTR)
Group Training
1800 Per Participant & excluding VAT/GST
02 - 06 Oct
09:00 AM - 05:00 PM CST
(8 Hours/Day)
06 - 10 Nov
09:00 AM - 05:00 PM CST
(8 Hours/Day)
Course Prerequisites
- Understanding of ISO 13485 concepts
- Knowledge of medical device regulations
- Experience in quality management system implementation
- Proficiency in project management
- Background in the medical device manufacturing
- Familiarity with risk management tools and principles.

ISO 13485 Lead Implementer Certification Training Overview

ISO 13485 Lead Implementer certification training is geared towards teaching professionals how to develop, implement, and manage a Quality Management System (QMS) for medical devices as per ISO 13485 standards. The course covers key topics such as understanding and interpreting the ISO 13485 requirements, risk management, documentation, internal audits, corrective and preventive actions, and the relationship between ISO 13485 and regulatory requirements. The training also prepares individuals to conduct third-party audits efficiently.

Why Should You Learn ISO 13485 Lead Implementer?

The ISO 13485 Lead Implementer course equips individuals with the expertise to support an organization in implementing and managing a Quality Management System based on ISO 13485. Benefits include increased marketability, career advancement opportunities, enhanced credibility, broadened knowledge and skills in quality management, and a potential increase in job performance and productivity.

Target Audience for ISO 13485 Lead Implementer Certification Training

- Quality Managers in the medical industry
- Regulatory Affairs Managers
- Professionals looking to develop a career in Quality Management Systems
- Medical Device development professionals
- Internal auditors in the medical devices industry
- Operations and Production Managers in Medical Device Companies

Why Choose Koenig for ISO 13485 Lead Implementer Certification Training?

• Certified Instructors: Gain comprehensive knowledge from experts in the field.
• Boost Your Career: Enhance professional credibility and increase job prospects.
• Customized Training Programs: Tailor-made courses to fit specific learning needs.
• Destination Training: Avail of training in multiple locations worldwide.
• Affordable Pricing: Quality education at competitive rates.
• Top Training Institute: Internationally recognized training institution.
• Flexible Dates: Choose from a wide range of class schedules.
• Instructor-Led Online Training: Interactive, live, and accessible learning.
• Wide Range of Courses: Diverse selection of industry-specific courses.
• Accredited Training: Certification and courses recognized globally.

ISO 13485 Lead Implementer Skills Measured

After completing ISO 13485 Lead Implementer certification training, an individual can gain skills such as understanding and interpreting the requirements of ISO 13485, planning, executing, reporting, and following up on a management system audit. They can also learn how to lead a team of auditors, manage an audit program, and communicate effectively with customers and regulatory agencies. This course can help them develop their planning and organizational skills, problem-solving abilities, and risk management expertise.

Top Companies Hiring ISO 13485 Lead Implementer Certified Professionals

Leading companies such as Johnson & Johnson, General Electric Healthcare, Stryker Corporation, Medtronic, Thermo Fisher Scientific, Boston Scientific, and Abbott Laboratories are actively seeking ISO 13485 Lead Implementer certified professionals. These companies thrive in the dynamic medical devices sector and emphasize on quality management systems.

Learning Objectives - What you will Learn in this ISO 13485 Lead Implementer Course?

The primary learning objectives of the ISO 13485 Lead Implementer course are to equip participants with the ability to understand and interpret the requirements and principles of ISO 13485 and how to apply them in the manufacturing process of medical devices. The course is designed to instill in-depth knowledge of the standard's requirements, quality management systems, risk management, the documentation process, and the role of leadership in effective implementation. It also imparts skills to conduct internal audit, manage non-conformity, and prepare for external audit. This knowledge empowers participants to drive continuous improvement in quality management practices within their organizations.
Student Name Feedback
United States
A1. Very good and informative session with her.
Jacqueline Op Den Kamp
United States
A1. Saroj is an excellent teacher; she knows a lot about the standards but also about the practical application. She constantly checks your level of knowledge per subject and adjusts to that. She is patient and has a pleasant personality to work with. I would love to have her as a colleague.


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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.
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Schedule for Group Training is decided by Koenig. Schedule for 1-on-1 is decided by you.
In 1 on 1 Public you can select your own schedule, other students can be merged. Choose 1-on-1 if published schedule doesn't meet your requirement. If you want a private session, opt for 1-on-1 Private.
Duration of Ultra-Fast Track is 50% of the duration of the Standard Track. Yes(course content is same).

Prices & Payments

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Travel and Visa

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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)
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