ISO 13485 Training in Karachi, Lahore, Islamabad, Pakistan, Dubai

ISO 13485 Lead Implementer Training

As an international standard, ISO 13485 determines the requirements for the medical devices industry. This standard was established to be used by companies during the life cycle of medical devices, from the production to post-production, including decommission and disposal. However, ISO 13485 can also be operated by other parties such as certification bodies which can assist in the certification processes. ISO 13485 serves as a tool for organizations to develop and retain their processes efficiently. Organizations that are striving for continuous improvement will benefit from this standard by being able to provide safe and competent medical devices and achieve the trust of customers.

Benefits of ISO 13485

By becoming an ISO 13485 certified professional, you will be able to:

Increase the number of job opportunities
Create new business connections
Gain competitive advantage
Increase effectiveness and lower costs
Offer expertise on improving work processes
Offer safer and more efficient medical devices
Increase customer satisfaction

How do I get started with ISO 13485 Training?

If you are willing to take the challenge of obtaining an ISO 13485 certification, our experts will ensure a qualitative experience where your needs will be met, and you will become part of our global network.

ISO 13485 Lead Implementer

Why should you attend?

ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.
After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Implementer” credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.

Who should attend?

Managers or consultants involved in Medical Devices Quality Management
Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
Individuals responsible for maintaining conformance with MDQMS requirements
MDQMS team members

Learning objectives

Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
Learn how to interpret the ISO 13485 requirements in the specific context of an organization
Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices

Educational approach

This training is based on both theory and best practices used in the implementation of a MDQMS
Lecture sessions are illustrated with examples based on case studies
Practical exercises are based on a case study which includes role playing and discussions
Practice tests are similar to the Certification Exam

Prerequisites

A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.

International Fee: 650USD

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