ISO 13485 Foundation Training Course in Kaduwela Sri Lanka

Instructor-led Live Online Classes


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


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


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


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

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


Wed - Wed
09:00 AM - 05:00 PM
18% Off

Key Features ISO 13485 Foundation Training Course in Kaduwela

1 Day Interactive Instructor –led Online Classroom or Group Training in Kaduwela Sri Lanka

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 Kaduwelaadhered with International Standards

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

Convenient Weekday/Weekend ISO 13485 Foundation Training schedule in Kaduwela Sri Lanka

About ISO 13485 Foundation Training in Kaduwela

The ISO 13485 family of Medical Devices Quality Management System is a set of standards that helps organizations ensure they meet customers and other stakeholder needs within statutory and regulatory requirements related to a product or service.
ISO 13485 Foundation Training in Kaduwela is an entry level course which teaches the fundamentals of a Medical Devices Quality Management System and the requirements of the ISO 13485 standard.
  • Other managers
  • Quality managers
  • Supervisors
  • Quality Systems Coordinators
  • Training Personnel
Unichrone offers you to deliver the requisite quality and efficiency by its globally recognized ITSM training and certification courses which enable individuals and companies to formulate the project in an efficient way. You furthermore have the selection of taking our online trainer led classroom or one to one ISO 13485 Foundation Training in Kaduwela at your very own convenience.

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

FAQs On ISO 13485 Foundation Training in Kaduwela

At the end of the program, you will be able to:
  • The purpose of a Medical Devices Quality Management System and its standards
  • The business benefits of improved performance as a result of a ISO 13485
  • The structure and content of ISO 13485
  • The specific Medical Devices Quality Management System related requirements of ISO 13485
  • You can enroll for the classroom training online. There are many options to pay either through your debit/credit card that includes Visa Card, MasterCard; American Express or - via PayPal. Payment receipt will be issued to the candidate automatically by email.
    Yes, you can revise the choice of city, place and date for any classroom training, if required. However, if it is cross-country, then there will be a revision in the training fee.
    Any registration cancelled within 48 hours of the initial registration will be refunded fully. Please note that refunds will be processed within 15 days of receipt of written request for refund.
    We do offer course completion certificate after you successfully complete the training program.
    Yes, we do offer discounts for the Classroom Training Program for group members.


    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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