ISO 13485 Lead Implementer Training

As per International Global Standards

  • Online/Group Sessions
  • 4 Days
  • Examination Included
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What is the ISO 13485:2016 Standard?

ISO 13485 Lead Implementer Certification is designed to validate the skill set of designing, managing, and implementing a quality management system for medical devices. The latest version of the ISO 13485 Standard was released in 2016. Organizations require certified professionals while applying this standard and its requirements into their structure. As a result, professionals certified with ISO 13485 Lead Implementer Certification get recognition from organizations that manufacture medical devices and related services. It is mandatory for medical device manufacturers to comply with the ISO 13485 Standard requirements. Organizations that are certified with ISO 13485 standard further reap the benefits of untapped markets and overall performance.

ISO 13485 Lead Implementer Certification Training

Pursuing ISO 13485 Lead Implementer Certification requires individuals to first attain the ISO 13485 Lead Auditor Certification. Professionals can apply for ISO 13485 Lead Implementer Training sessions offered by Unichrone. On completing the training sessions, candidates can take up the exam and score the required marks to obtain the certification of ISO 13485 Lead Implementer. During the training session, candidates gain a comprehensive understanding of the standard and its requirements. In addition, professionals can master the skills of maintaining MDQMS in conformance with the ISO standard. Individuals who are willing to broaden their scope and gain knowledge on ISO 13485:2016 standard can enroll for the training sessions conducted globally.

Key Features of ISO 13485 Lead Implementer Certification Training

ISO 13485 Lead Implementer Certification is designed to enable individuals in implementing the standard. Candidates enrolling for ISO 13485 Lead Implementer Certification Training gain practical knowledge of implementing the standard. Our certified trainers further assist professionals in attaining insights through real-time scenarios. This entitles certified Lead Implementers to implement the standard as per the requirements specified by ISO. Furthermore, candidates can enroll in live online method or in-class method of ISO 13485 Lead Implementer Training.

  • 4 Day Interactive Instructor –led Online Classroom or Group Training
  • Course study materials designed by subject matter experts
  • Mock Tests to prepare in a best way
  • Highly qualified, expert & accredited trainers with vast experience
  • Enrich with Industry best practices and case studies
  • ISO 13485 Lead Implementer Course adhered with International Standards
  • End-to-end support via phone, mail, and chat
  • Convenient Weekday/Weekend ISO 13485 Lead Implementer Training Course schedule
Corporate Group Training
  • Customized Training
  • Live Instructor-led
  • Onsite / Online
  • Flexible Dates
Request for Corporate Group Training
ISO 13485 Lead Implementer Exam Format
Exam Name ISO 13485 Lead Implementer Certification
Exam Format Multiple Choice
Total Questions 100 Questions
Passing Score 70% of Total Score
Exam Duration 120 Minutes

ISO 13485 Lead Implementer Course Curriculum

  • Topics

    • · Customer and regulatory focus
    • · Leadership
    • · Involvement
    • · The process approach
    • · Common tools
    • · Decision making
    • · Supplier management
    • · System management
    • · Continuous improvement

  • Topics

    • · Fundamentals of Quality Management Systems

  • Topics

    • · Requirements and Quality Systems

  • Topics

    • · Monitoring and measurement
    • · Control of non-conforming products
    • · The performance of the QMS
    • · Analysis of data
    • · Improvement of quality
    • · Corrective action
    • · Preventive action
    • · Identification of improvement opportunities

  • Topics

    • · Risk management principles
    • · The risk management process
    • · Risk lifecycle
    • · Risk management tools
    • · Risk management culture
    • · Assessments and control of risk management

ISO 13485 Lead Implementer Certification Benefits

Higher Salary

Earn 20% more salary than non-certified professionals in the field

Greater Responsibilities

Enhance your performance with additional responsibilities in the organization

Diverse Job Roles

Broaden your scope at the organization as compared to your peers

Global Recognition

Global recognition across different domains and industries with this certificate

Versatile Opportunities

Land at your dream job in large organizations with great expertise

Sophisticated Skillsets

Validates the advanced experience, skills and knowledge gained by professionals

Frequently Asked Questions

How will I benefit from ISO 13485 Lead Implementer Training?

Unichrone offers ISO 13485 Lead Implementer Training in flexible modes. Our trainers engage in hosting case studies and discussions related to the ISO standard. This assists professionals to gain a deeper understanding of the policies and procedures involved in ISO 13485:2016 standard.

Do you provide mock tests?

Yes, candidates can take up the mock tests on completion of ISO 13485 Lead Implementer Training.

Will I receive any certificate on completion of ISO 13485 lead Implementer Training?

Yes, candidates will receive a course completion certificate at the end of ISO 13485 Training.

How long is the ISO 13485 Lead Implementer Training?

The ISO 13485 Lead Implementer Training is conducted for 3 days in various countries.

How is the ISO 13485 Lead Implementer Exam conducted?

The ISO 13485 Lead Implementer Exam is conducted by Unichrone in online mode. The exam consists of multiple-choice questions which have to be completed within 120 minutes.

What is the passing score set for ISO 13485 Lead Implementer Exam?

The passing score for ISO 13485 Lead Implementer exam is set at 70%.

What is the re-examination policy?

Yes, candidates can retake the exam free for the second time. Subsequent attempts after 2nd attempt, the re-examination fees to be paid.

Who is a ISO 13485 Lead Implementer?

An ISO 13485 Lead Implementer is a professional who has the necessary skills to establish, implement and maintain an MDQMS. Certified lead implementers are responsible for analyzing the requirements of the standard. The requirements are then applied to the quality management system developed for medical devices. ISO 13485 Lead Implementation Certificate holders are hence known for assisting organizations with the standard.

Why do I need ISO 13485 Lead Implementer Certification?

The ISO 13485 Lead Implementer Certification is a globally recognized credential for quality management systems. Pursuing this certification broadens the scope of individuals looking for career opportunities in this field. In addition, professionals can land their dream jobs across various nations.

How can I obtain ISO 13485 Lead Implementer Certification?

Candidates opting for earning the ISO 13485 Lead Implementer Certification need to:

  • Enroll in ISO 13485 Lead Implementer Training course
  • Attempt the exam and score required minimum marks
  • Attain the certification on clearing the exam.

What next after getting certified as ISO 13485 Lead Implementer?

Individuals who have obtained the ISO 13485 Lead Implementer Certification can pursue a career in organizations that manufacture medical devices or related services. Certified professionals can assist businesses in designing a state-of-the-art MDQMS as per the standard. Lead Implementers are often offered the roles of quality analysts, quality engineers, operation managers, and quality specialists.

ISO 13485 Lead Implementer Examination Procedure


Attend intense 3 day ISO 13485 Lead Implementer Training offered by Unichrone. Fulfil all the requirements before the examination.


Apply for the ISO 13485 Lead Implementer Exam, conducted by Unichrone, whilst filling up all necessary details. Attend the exam scheduled at the end of the training session.


Score the minimum score to get certified after in the exam. You will receive an email confirming the status.

What our customers say

Kenneth Beard

Project Manager

Very engaging course with real world context and wonderful examples. Helped to expand my knowledge as a direct result of it.

Tom Eeartman

Head-Supplier Management

Super awesome faculty! The best part of the training was lots of real time case studies and interactive sessions. Learnt many new concepts.

Pavit Kenth

Technical Director MCI Ltd

Interesting, Focused, Real life case studies. The material was a comprehensive presentation of Lean principles and Six Sigma.

Saad Alsheddi

Head Of Operations

Really interesting, a lot of knowledge about processes, in many areas and departments, helped to understand the subjects easily.

Jernej Hercog

Manager-Engineering Services

I opted for Instructor led Online Session. The training was very well executed. It was awesome and exceeded my expectations.

Register for a free session with our trainer

Faculty and Mentors

Our certified and highly experienced trainers are handpicked from various industries to assist aspirants with practical insights into the field, thereby providing a comprehensive understanding of fundamentals and complex terminologies




Minimum Experience


Session Expertise

Professionals taking up ISO 13485 Lead Implementer Training incur the costs of course fee and exam fee.

The globally recognized and accepted certifying body governs the ISO 13485 Lead Implementer Exam.

Professionals who clear the ISO 13485 Lead Implementer exam, acquire the certification from Unichrone.

Management representatives and individuals who have acquired ISO 13485 Lead Auditor Certification can pursue the Lead Implementer Certification.


Have influence

Professionals taking up ISO 13485 Lead Implementer Certification get to develop personal skills to direct the implementation team. As a result, certified ISO 13485 Lead Implementers can influence the team and lead them in implementing the latest practices.


Take up managerial positions

ISO 13485 Lead Implementer Certification is the highest credential offered to individuals pursuing a career in the medical device industry. This empowers professionals certified as ISO 13485 Lead Implementers to take up managerial positions in the organization.


Be legitimate

ISO 13485 Lead Implementer Certification has gained recognition across various countries. Certified ISO 13485 Lead Implementers speak and implement the universal procedures required to comply with the requirements of the international standard.


Specialize your abilities

The ISO 13485 standard is updated at regular intervals with advancements in the field. Professionals pursuing the ISO 13485 Lead Implementer Certification master the latest implementation techniques required to fulfill the standard requirements.

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