ISO 13485 Lead Auditor Training (Medical Devices Quality Management System)

by Fox Star Management Development & Training

A course participation certificate is provided of 31 CPD (Continuing Professional Development) upon completion. This five-day course will empower you to develop necessary expertise for auditing a Quality Management System (QMS) for Medical D

AED 9000

Contact the Institutes

Fill this form
Fox Star Management Development & Training Logo

img Duration

5days

Course Details

Overview:

 

This five-day program will empower you to develop necessary expertise for auditing a Quality Management System (QMS) for Medical Devices with Medical Devices Quality Management System (MDQMS) manufacturers. By learning a wide variety of auditing principles and technique, you will be able to manage a team of auditors. 

 

You will learn to perform internal and external auditing in compliance with ISO 17021-1 and ISO 19011. You will also learn to manage MDQMS audit team on account of the new skills you wil learn in this program. Finally, you will be able to relate Medical Devices Quality Management System and compliance with customer and regulatory requirements

 

 

 

 

 

 

Outline:

 

 

Day 1: Introduction to Medical Devices Quality Management System (QMS) concepts as required by ISO 13485

 

 

Day 2: Planning and Initiating an ISO 13485 audit

 

 

Day 3: Conducting an ISO 13485 audit

 

 

Day 4: Concluding and ensuring the follow-up of an ISO 13485 audit

 

 

Day 5: Certification Exam

 

 

 

 

Features:

 

 

 

 

 

 

 

 

 

 

 

 

 

- Training is both theory and practice-based

 

 

 

 

- Real cases will be discussed during the training

 

 

 

 

- Practice test is included to familiarize you with exam

 

 

 

 

- Review exercises included

 

 

 

 

- Student manual will be provided with information and practical examples for you

 

 

 

 

- Under certain conditions, the students are allowed to re-take the exam in case of failure.

 

 

 

 

 

 

 

 

 

 

 

 

Certificate:

 

 

 

 

 

 

 

 

 

 

 

 

 

1. A course participation certificate is provided of 31 CPD (Continuing Professional Development) upon completion.

 

 

 

 

2. Once the exam is passed and you comply with all requirements for this credential, another certificate will be provided to you.

 

 

 

 

 

 

 

 

 

 

 

 

 

Note: Certification and exam fee included in the price. (Pricing are subject to change without any prior notice)

 

 

 

 

 

 

 

 

 

Credentials:

 

 

 

 

 

 

 

 

 

 

Depending on your level, you can apply for the following credentials after completing the exam;

 

 

 

 

 

 

 

 

 

 

- Certified ISO 13485 Provisional Auditor

 

 

 

- Certified ISO 13485 Lead Auditor

 

 

 

- Certified ISO 13485 Auditor

Special Message

Pricing are subject to change without proir notice

Fox Star Management Development & Training is a leading institute for training and development courses in Dubai. Based on the Core Values of commitment to Quality, Honesty and Excellence, Fox Star Management Development & Training promises to offer training courses for career development and professional growth to individuals and organizations. 

 

Partners:

 

- PECB

- PSA (The International Protective and Security Academy)

- IOSH *Working Safely and Managing Safelt 5.0

 

Approved By:

 

 

 

 

 

Knowledge and Human Development Authority KHDA

  • Deira Branch

    Baniyas St., Al Masraf Tower, Deira, Dubai
  • Teacher's Name
  • N/A
  • Teacher's Experience
  • PECB Certified Trainer

  • Gender
  • N/A
  • Teacher's Nationality
  • N/A

Check out more ISO 13485 (Medical Devices) courses in UAE

TÜV SÜD Middle East Logo

ISO 13485 Awareness Training

Awareness Training Program Based on ISO 13485:2016 Standard (Medical Device)

by TÜV SÜD Middle East
GRCA Academy Logo

ISO 13485 Internal Quality Auditor

This training will introduce the delegates to the knowledge and principles of ISO 13485 which pertains to the quality management system requirement for medical devices.

by GRCA Academy
Fox Star Management Development & Training Logo

ISO 13485 Lead Implementer Training (Medical Devices Quality Management System)

A course participation certificate is provided of 31 CPD (Continuing Professional Development) upon completion. This 5-day course will train you to support implementation and management of Medical Devices Quality Management System (MDQMS) a

by Fox Star Management Development & Training
Fox Star Management Development & Training Logo

ISO 13485 Foundation Training (Medical Devices Quality Management System)

A course participation certificate is provided of 14 CPD (Continuing Professional Development) upon completion. The participant will learn different components of an MDQMS (Medical Devices Quality Management System) such as quality manual, r

by Fox Star Management Development & Training
Fox Star Management Development & Training Logo

ISO 13485 Introduction Training (Medical Devices Quality Management System (MDQMS)

A course participation certificate is provided of 7 CPD (Continuing Professional Development) upon completion. This training will familiarize you with the basic concepts of implementing and managing Medical Devices Quality Management System

by Fox Star Management Development & Training

© 2024 www.coursetakers.ae All Rights Reserved. Terms and Conditions of use | Privacy Policy