ISO 13485 – Medical Device – Quality Management Systems –Requirements for regulatory purpose – address the development, implementation and maintenance of quality management system intended for use by medical device manufacturers, developers, and suppliers. The standard details the requirement for quality management systems, to meet customer requirement and allows the incorporation of applicable regulatory requirements within an organization’s quality management system.

The course will make participants understand of ISO 13485 Requirements and how to approach implementation.

Course Objectives

  • Provide a basic understanding of ISO 13485 Standard’s requirements
  • Provide understanding on Integration of ISO 13485 requirements in ISO 9001 QMS

Date and Time

Date : 5th Aug 2020

Time : 10.30 am to 12.30 pm

Who should attend ?
  • Management Representative for Medical Devices QMS
  • QA Professionals in Medical Devices Field
  • Core Team Members of Medical Devices – QMS Team
  • Internal Auditors of Medical Devices QMS
  • External Auditors of medical Devices QMS
  • Students having interests in Medical Devices
Course Contents
  • Basic Introduction to ISO 13485: 2016
  • Relation ISO 9001:2015 / ISO 13485:2016
  • Key issues addressed by ISO 13485:2016
  • Integration of Risk Management ISO 14971 in ISO 13485

Softcopy Certificate of successful attendance shall be issued to all the delegates who attend entire duration of the course.


2 Hours

Registration Fees

Rs. 1500/- + 18 % GST Only

Registration and Payment 

Registration with confirmed payment will be closed 2 Hours before the scheduled time of Webinar.

Cancellation Policy

In case of schedule cancellation by the delegate, fees will be non-refundable.