Key points about this course

ISO 13485 Implementer

Title: ISO 13485 Implementer

Duration: 2 Days

Certification Exam(s): ISO 13485 Implementer

Accredited: No

Pre-course Reading: None

Rating: 4.5 Stars

Support: Provided by Tecknologia

 

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.

Continue Reading...

Select your preferred delivery method

Select a Month

Online Instructor-Led

Aug 11, 2021

Places Available

1195

(ex. VAT)

Book Now

Online Instructor-Led

Sep 15, 2021

Places Available

1195

(ex. VAT)

Book Now

Online Instructor-Led

Oct 13, 2021

Places Available

1195

(ex. VAT)

Book Now

Online Instructor-Led

Nov 17, 2021

Places Available

1195

(ex. VAT)

Book Now

Online Instructor-Led

Dec 15, 2021

Places Available

1195

(ex. VAT)

Book Now

Online Instructor-Led

Dec 20, 2021

Places Available

1195

(ex. VAT)

Book Now

 

Select a Month

Online Instructor-Led

Aug 11, 2021

Places Available

1195

(ex. VAT)

Book Now

Online Instructor-Led

Sep 15, 2021

Places Available

1195

(ex. VAT)

Book Now

Online Instructor-Led

Oct 13, 2021

Places Available

1195

(ex. VAT)

Book Now

Online Instructor-Led

Nov 17, 2021

Places Available

1195

(ex. VAT)

Book Now

Online Instructor-Led

Dec 15, 2021

Places Available

1195

(ex. VAT)

Book Now

Online Instructor-Led

Dec 20, 2021

Places Available

1195

(ex. VAT)

Book Now

 

Select a Country
Select a Location
Select a Month

There are no training slots currently available for Classroom method of delivery. Why not check Virtual Classroom slots?

Alternatively, please Contact us and we may be able to help you.

Course Information

Overview
Prerequisites

There are no pre-requisites for attending this course. 

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.  

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.


Related Courses You May Be Interested In:


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.

Tecknologia1621785858_ISO 13485.png Tecknologia1621785858_ISO 13485.png123 /uploads/1621785858_ISO 13485.png