ISO 13485 Lead Implementer Course

  1. Language


  2. Duration

    30 hours

  3. CPE


  4. Course type

    Online self-paced + live online workshop

  1. Course benefits:

    • Improve your knowledge of ISO 13485 implementation techniques
    • Learn how to lead an ISO 13485 implementation project
    • Add new skills to your resume and expand your business

    This free ISO 13485 Lead Implementer course will teach you how to become an independent consultant or practitioner for the implementation of a medical device QMS using the ISO 13485 standard, and how to build your consultant business.

    After passing the exam, you will receive a certificate, accredited by ASIC, which proves your expertise as an ISO 13485 Implementer and enhances your consulting practice, as most organizations seek out certified consultants.

    This ISO 13485 Lead Implementer training is divided into three parts:

    1. A video library: includes lessons and practical information about the standard and how to implement ISO 13485 in your company or at your client
    2. An interactive workshop: helps you practice the concepts necessary for implementing ISO 13485 guided by our top experts
    3. Certification exam: upon successful completion of the ISO 13485 Lead Implementer exam, you will get a certificate and a badge for your LinkedIn profile to highlight your qualifications

    Who should attend:

    • Project and quality managers involved in ISO 13485 implementation
    • Novice consultants seeking to learn new expertise
    • Experienced consultants needing proof of their competence in ISO 13485 implementation


    • There are no prerequisites to attend this course.

Online course

Please expect an email from titled "Please register for your exam." This email will usually arrive within one business day of purchase.

Your time slot for the exam will be open right after your complete the system check. You will be able to enter the session the moment you click on the link from the email titled "You are now ready to take your exam" as seen here.

Please contact us at if you need our help.

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Course Instructors

ISO 13485 Lead Implementer Course - Advisera

Kristina Zvonar Brkic

ISO 13485 Expert

Kristina Zvonar Brkic is an experienced consultant, auditor, assessor, and trainer for ISO 13485 and EU MDR. She runs a thriving ISO 13485 consulting practice and helps companies and consultants to build their businesses. In her career, she also worked as an ISO 9001 and ISO 22716 consultant and lead auditor, and auditor and assessor for MDD.

ISO 13485 Lead Implementer Course - Advisera

Garry Cornell

ISO Consultant, Trainer, and Auditor

Garry Cornell has more than 25 years of global experience as a senior manager, certification auditor, and consultant, helping a wide range of businesses in their implementations of ISO 14001, ISO 45001, and ISO 50001. He has developed various courses and is the author of several books on auditing techniques and ISO 14001. He is a member of the Institute of Environmental Management and Assessment.

Why Advisera ISO 13485 Lead Implementer Course?

ISO 13485 Lead Implementer Course - Advisera

Free unlimited access to the entire course

ISO 13485 Lead Implementer Course - Advisera

Globally recognized accreditation by ASIC

ISO 13485 Lead Implementer Course - Advisera

Expert support from Advisera's top experts

ISO 13485 Lead Implementer Course - Advisera

400 students have attended this course already

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