ISO 13485 Foundation Training Course in Essen Germany

Instructor-led Live Online Classes


Wed - Wed
09:00 AM - 05:00 PM
10% Off


Fri - Fri
09:00 AM - 05:00 PM
10% Off

Classroom Training Sessions Please check availability with our staff before enrolling for Classroom


Tue - Tue
09:00 AM - 05:00 PM
15% Off

Key Features ISO 13485 Foundation Training Course in Essen

1 Day Interactive Instructor –led Online Classroom or Group Training in Essen Germany

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 Foundation Course in Essen adhered with International Standards

End-to-end support via phone, mail, and chat

Convenient Weekday/Weekend ISO 13485 Foundation Training schedule in Essen Germany

About ISO 13485 Foundation Training in Essen

The ISO 13485 Standard deals with benchmarks that are supposed to be met by manufacturers and suppliers of Medical Devices, whilst ensuring the needs of stakeholders and customers are fulfilled.
ISO 13485 Foundation Training in Essen is an entry level course which teaches the fundamentals of a Medical Devices Quality Management System and the requirements of the ISO 13485 standard.
The ISO 13485 Foundation training can be preferred by individuals who are:
  • Part of the Medical Device Quality team,
  • Employed in the Medical Device Industry, and
  • Responsible for proper execution of ISO 13845 standard
  • There are no prerequisites prescribed for taking up ISO 13485 Foundation Training Course.
    Unichrone offers 1-day intensive training of ISO 13485 Foundation Course in Essen. Once participants enroll for the course, they can access the course material which includes recent case studies and mock tests aligned according to the ISO 13485 Foundation Exam.
    We offer flexible schedules in both classroom and online training modes.
    The ISO 13485 Course introduces the basic concepts involved in Medical Device Quality Management System.

    ISO 13485 Foundation Training Curriculum

    Introduction to ISO 13485:2016

    Importance of ISO 13485 for an organisation

    An Overview of ISO 13485:2016 Requirement

    General requirements & Documentation requirements

    Management responsibility, Resources

    Product realisation, Infrastructure, Risk Management

    Implementation Phases of the ISO 13485 Frameworks

    Stages to implementation, Gap Analysis, Process mapping

    Conducting an ISO 13485 Certification Audit

    The relationship between ISO 13485 and ISO 9001

    Download ISO 13485 Foundation Training Course Brochure

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    ISO 13485 Foundation Certification Format

    ISO 13485 Foundation Examination and Certification in Essen
    The ISO 13485 Foundation Certification Examination in Essen can be done via Online Mode.
    Duration: 1 Hour
    Certification Body: TUV-SUD (Globally Recognized and Accepted)

    FAQs On ISO 13485 Foundation Training in Essen

    At the end of the program, you will be able to:
  • Understand the purpose of the Medical Devices Quality Management System and its standards
  • Improve the performance of the business as a result of ISO 13485
  • Develop and structure the content of ISO 13485
  • Gain a comprehensive understanding of specific Medical Devices Quality Management System related requirements of ISO 13485
  • The ISO 13485 Foundation Exam is conducted through online mode on completion of the training program.
    The exam duration is 1 hour.
    Participants of the ISO 13485 Foundation Course can be a part of the auditing team on successful completion of the exam.
    If candidates do not clear the exam in the first attempt, they can retake the exam for within 6 months from the date of last attempt.
    Yes, the training fee for ISO 13485 Foundation Course includes the exam fee.


    Pavit Kenth

    Technical Director MCI Ltd

    Interesting, Focused, Efficient. The material was a comprehensive presentation of Lean principles and a good overview of Six Sigma. I feel like I have a good understanding of the basics of Lean Six Sigma.

    Saad Alsheddi

    Head Of Operations at Ministry of Finance

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

    Kenneth Beard

    Project Manager

    Very engaging course with real world context and wonderful examples. I have greatly expanded my knowledge as a direct result of this class and I look forward to applying this in my daily personal and work life.

    Neesha Rambharrack

    Team Lead-Projects&Facilities Engineering

    If you are looking for a culture shift, Unichrone’s trainings are the vehicle that can take you there. The results speak for themselves.

    Jernej Hercog

    Manager Engineering Services at Clariant

    I opted for Instructor led Online Session. The training was very well executed and there will always be a Unichrone's staff to assist online always in session.

    Tom Eertman

    Head of Supplier Management

    Super awesome faculty!! The best part of the training was lots of real time case studies, fun and interactive sessions. Loved being part of it.

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