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Key points about this course

ISO 13485 Implementer Training Course

Title: ISO 13485 Implementer

Duration: 2 Days

Certification Exam(s): ISO 13485 Implementer

Accredited: No

Pre-course Reading: None

Rating: 4.5 Stars

 

Dates and Prices Course Information

 

ISO 13485 Implementer Training Course

ISO 13485 is a quality standard for the manufacture and design of medical devices. This ISO 13485 course guides on the standard in detail, delivering the understanding of its clauses helping the businesses in improving manufacturing quality while reducing defects.

Why Choose Tecknologia

  1. No pushy sales calls & no marketing emails, ever!
  2. Physical handbook(s) included (where applicable).
  3. No more than 12 delegates in public classroom training.
  4. Delegates are never dumped after payment has been made.
  5. Delegate friendly terms and conditions (including refund policy).
  6. The best learning experience delivered, always !

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May 15, 2024

Places Available

1650

(ex. VAT)

Book Now

Jun 12, 2024

Places Available

1650

(ex. VAT)

Book Now

 

Select a Month

May 15, 2024

Places Available

1650

(ex. VAT)

Book Now

Jun 12, 2024

Places Available

1650

(ex. VAT)

Book Now

 

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Course Information

Overview

ISO 13485:2016 is an international standard that defines the requirements of quality management systems for organisations that design, develop, manufacture, and implement medical devices. It also includes services regarding design and development of material or component parts used in the medical devices. The most recent version of the standard was published in March 2016.

Course Outline

Following modules/ topics will be covered in ISO 13485 course:

Module 1: Introduction to ISO 13485:2016

  • What is ISO 13485:2016?
  • Importance of ISO 13485 for an organisation

Module 2: A Overview of ISO 13485:2016 Requirements

  • General requirements
  • Documentation requirements
  • Management responsibility
  • Resources
  • Product realisation
  • Infrastructure
  • Risk management

Module 3: Implementation Phases of the ISO 13485 Frameworks

Who Should Attend?

This course is suitable for professionals involved in the manufacture and design of medical devices or related field.  

Prerequisites

There are no pre-requisites for attending this course. 

Virtual classroom trainings are held using video conferencing software. A trainer leads the class for the duration of course. Delegates may attend the session using PC, laptop or tablets.

No, this course is not accredited by any certification body.

Tecknologia trainers are highly experienced practitioners with excellent training delivery capabilities. Our trainers are accredited by various bodies for relevant training deliveries.

This instructor lead course includes following:

  • Training Delivery Over 2 Days
  • Course Material
  • Course Completion Certificate

Refreshments (tea/ coffee) will be provided free at venue for classroom courses.


Delegates Testimonials!

ISO 13485:2016 is an international standard that defines the requirements of quality management systems for organisations that design, develop, manufacture, and implement medical devices. It also includes services regarding design and development of material or component parts used in the medical devices. The most recent version of the standard was published in March 2016.

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