IMPLEMENTING ISO 13485 MEDICAL DEVICES

NAME OF THE COURSE
Implementing ISO 13485 Medical Devices Training
 
CERTIFICATION
Implementing ISO 13485 Medical Devices Training
 
COURSE OVERVIEW
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

With over 150 BSI QMS assessors globally supported by BSI product experts, our ISO 13485 certificates are known and trusted in the medical device industry by authorities, suppliers and manufacturers around the world.
 
TRAINING DURATION
Total Training Hours : 22 Hours
Training Duration      : 1 Week
Total Training  Days  : 4-5 Working Days
 
TRAINING SCHEDULE
Weekdays (Sunday to Thursday)
Regular Sessions : 4 – 6 Hrs Per day (9am to 2pm or 3.00pm to 9.00 pm)
Food & refreshments Included
Weekends (Friday & Saturday)
Fast Track Sessions: 8 Hours per day (9am to 5pm)
Food & refreshments Included
 
CERTIFICATION
Globally recognized certificate from “Kings Global Career Academy”
 
TEST
No
 
LEARNING AIDS
Yes
 
COURSE MATERIAL
Hard & Soft Copies of Study Material
 
LANGUAGE OF INSTRUCTION
English
 
INSTRUCTOR HELPLINE
Yes
1. Email
2. Social Media (For Emergency requirements)
 
REGISTRATION REQUIREMENTS
1. Passport Copy
2. Curriculum Vitae
3. Passport size photographs
4. Course Fee
 
MODE OF PAYMENT
Cash / Cheque / Credit Card / Bank Transfer.
 
WHO SHOULD ATTEND 
Managers, executives, supervisors and management staff who want to gain knowledge on ISO 13485:2016 Medical Devices and staff who are likely or currently involved in implementing and maintaining ISO 13485:2003 and key personnel assigned for internal audits, management representatives (MR), etc
 
COURSE BENEFITS
Increase access to more markets worldwide with certification
Outline how to review and improve processes across your organization
Increase efficiency, cut costs and monitor supply chain performance
Demonstrate that you produce safer and more effective medical devices
Meet regulatory requirements and customer expectations
 
COURSE CONTENTS
The course includes a high level of interactivity during training on:
  • Interpret all clauses of ISO 13485:2003
  • Understand differences between ISO 13485:2003 and ISO 13485:2016
  • Understand the Quality Management Principles
  • Apply principles of the ISO 19011 to the auditing process
  • Plan, conduct and report effective internal audits to the ISO 13485:2016
  • Cost savings through improved efficiency and productivity
  • A better definition of roles and key responsibilities for employees
  • Systematically provide medical devices and services that consistently meet customer requirements
  • Fulfil regulatory requirements
 
Awareness Course
  • Related concepts, principles and interpretation of the ISO 13485:2016 standard
  • Reasons for the changes from the previous ISO 13485:2003 standard
  • Overview of the significant changes from the previous ISO 13485:2003 standard
  • Impact of the changes on your organisation and audits
 
Internal Auditor Course 
  • Related concepts, principles and interpretation of the ISO 13485:2016 standard
  • Reasons for the changes from the previous ISO 13485:2003 standard
  • Overview of the significant changes from the previous ISO 13485:2003 standard
  • Impact of the changes on your organisation and audits
  • How to prepare internal audit plans, conduct internal audit preparations, conduct internal audits, reporting of non-conformance and conducting of follow-up verification
REGISTER