ISO 13485 – MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM

ISO 13485 – Medical Device Quality Management System

Context:

The ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Device Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques. During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and the certification process according to ISO/IEC 17021-1.

Through extensive examination of your knowledge and personal attributes, Medical Device Management Systems Lead Auditor training can give you proof of your competence to effectively audit management systems of organizations that produce medical devices and gives you an assurance that your audits will be accepted globally.

Training Courses:

MDQMS Awareness(ID 4777676):

We shall deliver the knowledge about the requirements of the ISO 13485 standards. You will understand the concepts, approaches, methods, and techniques used to implement a Medical Device Quality Management System. Training material containing information and practical examples will be distributed.

Recognition: This training is recognized by Exemplar Global. Duration: 2 Days. Exam Requirement: No. Prerequisites: No.

MDQMS Internal Auditor(ID 4777675):

This course is for those who require full knowledge of how to conduct an internal audit of a Medical Device Quality Management System. Ideally suited to those who have to develop, implement, maintain, improve, manage or audit against ISO 13485, our Medical Device Quality Management System Internal Auditor course will leave you ready to hit the ground running.

Recognition: This training is recognized by Exemplar Global. Duration: 2 days. Exam Requirement: No. Prerequisites: No.

MDQMS Lead Auditor(ID 4777674):

Want to be an MDQMS Lead Auditor, and if you are seeking knowledge to prepare yourself to perform and lead Medical Device Quality Management System certification audits, we highly recommend you attend this course. Throughout the course, participants will complete a series of workshops that form part of the assessment. A short multiple-choice exam at the completion of each module assesses the knowledge and understanding gained throughout the training. Participants receive continual assistance and feedback from the trainer and are given anecdotal examples of real-world audit situations.

Recognition: This training is recognized by Exemplar Global. Duration: 5 days. Exam Requirement: Yes. Prerequisites: No.

Delivery

Face to face

Our regular public courses are conducted in various places across the world. You will enjoy an excellent learning experience in a premium training venue, and;

We never cancel courses – book with confidence
Class sizes are kept to manageable numbers – so everybody learns
No homework or take-home assessment! All work is completed in course time – we know you’re busy
No major exam – we assess you as you go

Public – Virtual/Online

In response to COVID-19 and social distancing, we’ve developed an online digital classroom to deliver our courses virtually and keep the interaction and engagement between trainers and participants. Our virtual training platform incorporates:

Group exercises – facilitated by mini break out workshops amongst the team
Ability to ask questions in real-time
Built-in note-taking and tracking of course materials
You can interact with participants throughout the session through a chat functionality
Online assessments providing a streamlined marking process

Our aim is to recreate the classroom experience in a safe, virtual environment, maintaining the fun and engaging experience our clients find useful and valuable.

Live Online Training (Instructor-Led Training)

We can also organize a group training to suit your company needs.

E-Learning (100% Online Private Study)

Group Training – Face to face (In-house training at your facility) or virtual

We can also organise a group training publicly to suit your company needs. Contact us for a quote and to discuss your company training needs.

Enroll:

Please complete the online registration form at : Click here