ISO 13485 Lead Implementer Training

As per International Global Standards

  • Online/Group Sessions
  • 4 Days
  • Examination Included
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How does ISO 13485 Lead Implementer Certificate enhance your career opportunities?

ISO 13485 Certification can provide a competitive edge in the medical device industry. Companies having ISO 13485 Certification show their dedication to safety, compliance, and quality. The certification helps in standing out from healthcare suppliers or providers. It also helps businesses to find areas for refinement for increasing production. Professionals owning ISO 13485 Lead Implementer Certificate set up and oversee a Medical Device Quality Management System (MDQMS) as per legal regulations. Individuals become experts in their field and can pursue opportunities for leadership positions. Also, earning the certificate gives them an edge in the ISO 13485 Lead Implementer Interview in .

ISO 13485 Lead Implementer Certification Training

The ISO 13485 Lead Implementer Certification exhibits a professional's proficiency in installing MDQMS. This enhances their professional reputation and credibility globally. ISO 13485 Lead Implementer Training assists professionals in establishing, implementing, and managing MDQMS. It enables learners to comprehend the relationship between international regulations and ISO 13485. Aspirants who complete ISO 13485 Training gain communication and leadership abilities. This aids in coordinating the internal environment of the organization during implementation phase. Certified professionals interpret the requisites of the standard and design MDQMS accordingly.

Key Features of ISO 13485 Lead Implementer Certification Training

ISO 13485 Lead Implementer Training equips professionals with the skills to apply MDQMS. This course is for technical specialists, MDQMS team members, managers, and leaders. Unichrone offers live online method and in-class method of ISO 13485 Lead Implementer Training. Candidates enrolling in this training learn the know-how of complying with the standard. Qualified experts carry out the training course and offer their insights on ISO 13485. This entitles professionals to administer the standard as per the requirements specified by ISO.

  • 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
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  • Customized Training
  • Live Instructor-led
  • Onsite / Online
  • Flexible Dates
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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.

Will ISO 13485 improved customer satisfaction?

A medical device QMS aids organizations in delivering more consistently high-quality goods and services, enhancing the reliability and capacity of their products to satisfy consumers. This improved quality increases customer satisfaction.

What are the two stages of the company’s ISO 13485 Certification process?

ISO 13485 Certification process is divided into two stages:

  • Stage 1(documentation review): The auditors from the selected certification organization will make sure that the documentation complies with ISO 13485 criteria.
  • Stage 2(main audit): The certification body auditors will examine documents, records, and business procedures to see if the organization's actual operations are consistent with both ISO 13485 and its own documentation.

Why should an organization conduct Gap Analysis?

Gap Analysis are carried out by organizations when adopting ISO 13485. Lead Implementer evaluates the organization's current procedures and contrasts them with the standards of ISO 13485 to perform a gap analysis. By doing this, the organization will be able to identify the gaps between its existing system and the system it will need to develop to comply.

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.

ISO 13485 is the medical device quality management standard. It outlines the requirements that must be met by a company before it can develop and operate a quality management system. By doing this, they can show that they can deliver medical equipment and related services that consistently satisfy clients and adhere to legal standards.

ISO 13485 is not mandatory. However, ISO 13485:2016 is the only MDQMS standard that is on the EU list and complies with EU MDR. As a result, medical product manufacturers adhere to ISO 13485:2016 specifications to fulfill EU MDR criteria.

  • Clause 1: Scope
  • Clause 2: Normative Reference
  • Clause 3: Terms and Definitions
  • Clause 4: General Requirements
  • Clause 5: Management Responsibility
  • Clause 6: Resource Management
  • Clause 7: Product Realization
  • Clause 8: Measurement, Analysis, and Improvement

The latest version of the ISO 13485 Standard is ISO 13485:2016. It was published in 2016.

The ISO 13485 Certification is provided by certification bodies that are authorized to carry out audits and issue certifications for compliance with the ISO 13485 Standard. These certification bodies are independent organizations that have been assessed and accredited by recognized accreditation bodies.

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.

The following are the steps involved in getting ISO 13485 Certification
  • Planning the quality system
  • Meeting regulatory requirements
  • Implementing design controls
  • Documents, records, and training
  • Management processes
  • Certification audit

The following aspects emphasize how crucial it is to possess an ISO 13485 Certification:
  • Superior manufacturing techniques
  • Commitment to ongoing progress
  • Credibility
  • Competitive advantage among peers
  • Adhering to the rules and regulations

No, the ISO 13485 Certification does not extend to non-medical businesses. ISO 13485 is intended for organizations involved in designing, producing, installing, and servicing medical devices and related services.

The duration of an ISO 13485 Certification is three years. The organization conducts annual surveillance audits to monitor their progress. It also helps to determine whether its current procedures are up to date and whether quality standards are still being upheld.

It is important for the ISO 13485 Lead Implementer to allow top management to assess the company's quality objectives before submitting for the third-party audit. Following the evaluation, management creates a finalized list of improvements and action items uncovered during internal audits. The list might then serve as a blueprint for the subsequent management assessment before submitting an application for 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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