ISO 13485 Foundations Course

  1. Language


  2. Duration

    8 hours

  3. CPE


  4. Course type

    Online self-paced

  1. Course benefits:

    • Understand the basics of ISO 13485
    • Learn the best practices for ISO 13485 compliance
    • Add new skills to your resume

    This beginner-level course will teach you all that you need to understand the ISO 13485 standard and help you get familiarized with all the key concepts of a medical device QMS, like planning of product realization, design and development, validation processes, identification and traceability, management commitment, continual improvement, etc.

    After passing the ISO 13485 Foundations exam, you will receive a certificate, accredited by ASIC, which proves your proficiency in the ISO 13485 standard.

    This ISO 13485 Foundations course is divided into two parts:

    1. A video library: includes lessons and practical information about the basics of the standard
    2. Certification exam: upon successful completion of the exam, you will get a certificate and a badge for your LinkedIn profile to highlight your qualifications

    Who should attend:

    • Team members involved in ISO 13485 implementation
    • Persons wanting to learn the basics of the ISO 13485 standard
    • Persons seeking to acquire new expertise and start a career in medical devices Quality Management Systems


    • There are no prerequisites to attend this ISO 13485 Foundations 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.

Course Instructor

ISO 13485 Foundations 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 an auditor and assessor for MDD.

Why Advisera ISO 13485 Foundations Course?

ISO 13485 Foundations Course - Advisera

Free unlimited access to the entire course

ISO 13485 Foundations Course - Advisera

Globally recognized accreditation by ASIC

ISO 13485 Foundations Course - Advisera

Expert support from Advisera's top experts

ISO 13485 Foundations Course - Advisera

500 students have attended this course already

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