What is ISO 13485 Training?

ISO 13485 Lead Auditor is not the only choice. There are actually 8 Auditor Courses for ISO 13485 to choose from including a Lead Implementer Certification.

Conventional classroom-based auditor courses for ISO 13485: 2016 (Medical Device Management System Standard) usually limit you to two choices. One is a 2-day internal auditor course and the other is a 5-day lead auditor course.

Because of this, selecting an appropriate ISO 13485 auditor course can be problematic. There is no such restriction when it comes to e-learning-based courses.

Online Iso 13485 Training

With our web-based ISO 13485 training courses, interested learners have the flexibility to choose when and where they want to train.

Not only that, they also have the freedom to choose which Medical Device Management System course they want to take.

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The Regulatory Framework

ISO 13485 compliant management systems must incorporate compliance with applicable regulations. These are primarily determined by the location where it is proposed to sell the medical devices.

These regulations can be a ‘minefield.’ If you are new to the medical device sector, you’ll need expert advice. This is to ensure that you are implementing and maintaining the ‘right’ Medical Device Management System (MDMS).

Regional Regulations

To get a quick overview of different regional regulations, please refer to the links below.

EU Regulatory Area: EC Medical Devices Website

US Regulatory Affairs: US FDA Medical Devices Website

MDSAP – Medical Devices Single Audit Program. This is a worldwide initiative by regulatory bodies to simplify inspections / audits. See the IMDRF website

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Here you'll find the ISO 13485 Training Course you want

Your specific situation will determine which is the best course for you.

I want ISO 13485:2016 Internal Auditor Certification

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This is the online ISO 13485 training you need to carry out effective internal audits.

See the ISO 13485 training you need to carry out effective internal audits here.

I'm newly responsible for my organization's MDMS

Quality Managers who don’t feel confident about ISO 13485: 2016 and its requirements are suited for this course. It will help you understand what an efficient and effective Medical Device Management System looks like.

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We manufacture medical device components. I've been tasked with getting our ISO 13485 certification. Which course should I take?

Our ISO 13485 Lead Implementer is ideal for you. You may need some consultancy support on implementation, but that should be limited. Furthermore, you’ll know the ‘right’ questions to ask.

Implementing a Medical Device Management System yourself can be challenging. However, it’s a great way to quickly introduce changes needed to secure and retain ISO 13485 certification.

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I'm an MDMS Lead Auditor and want to upgrade to the new Standard.

You’ll be an ISO 13485:2016 Lead Auditor with this 24-hour Conversion Course.

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I'm already a Lead Auditor and I'd like to add ISO 13485:2016 to my auditor certification

With this 24-hour Extension Program you will become a certified ISO 13485:2016 Lead Auditor.

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I want ISO 13485:2016 Lead Auditor Certification

Provides in-depth knowledge of the Standard and of Auditing skills. This is the certification you need if you hope to audit for a Certification Body.

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We're certified in the old standard. Now, I want to upgrade our MDMS to meet the ISO 13485: 2016 requirements.

This Transition Training package includes an ISO 13485: 2016 Implementation Handbook. Packed along with it is a documentation toolkit, lots of sample paperwork, and a Gap Analysis Tool.

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I want to implement ISO 13485:2016 for my organization

This course includes a 33-step Path to Certification and a 100+ page ISO 13485: 2016 Implementation Handbook. It also contains loads of sample SOPs and forms. There’s Auditor Certification for yourself as well.

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I'm a MDMS Internal Auditor and need to learn about the revised Standard

With this 8-hour Conversion Course, you’ll become a certified ISO 13485: 2016 Internal Auditor. Moreover, you can get it at a fraction of the usual time and cost it takes to finish the course.

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