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

This 5-day program will train you to support implementation and management of  Medical Devices Quality Management System (MDQMS) as per  ISO 13485:2016. Based on the instructions provided by ISO 13485, you will learn to implement quality processes and understand the best practices in this regard.

This program complies with the principles of project management practices established in ISO 10006.  You will be able to comply MDQMS with regulatory requirements and customer, and learn to prepare an organization for ISO 13485 audit.

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 Implementer

- Certified ISO 13485 Lead Implementer

- Certified ISO 13485 Implementer