ISO 13485 Lead Auditor is not the only choice – there are 8 Auditor Courses for ISO 13485 to choose from including a Lead Implementer Certification
Conventional classroom-based Auditor Courses for ISO 13485, the Medical Device Management System Standard, usually limit you to two choices. Either a 2-day Internal Auditor Course or a 5-day Lead Auditor Course. To select an appropriate ISO 13485 auditor course can be problematic. There are no such restrictions when it comes to e-learning-based Courses.
And the choice of Auditor Courses means you can get a Course that directly matches your needs.
The Regulatory Framework
ISO 13485 compliant management systems must incorporate compliance with applicable regulations, which are primarily determined by the location where it is proposed to sell the medical devices. The regulations are truly a ‘minefield’ and, if you are new to the medical device sector, you’ll need expert advice to ensure that you implement and maintain the ‘right’ Medical Device Management System (MDMS).
To get you started …
EU Regulatory Area: EC Medical Devices Website
US Regulatory Affairs: US FDA Medical Devices Website
MDSAP – Medical Devices Single Audit Program, a worldwide initiative by regulatory bodies to simpify inspections/ audits: IMDRF Website
The Courses in each Program...
You'll find the Course you want here
Your current circumstances will dictate which is the best choice for you.
I want ISO 13485:2016 Internal Auditor Certification
The certification you need to carry out effective internal audits.
I'm newly responsible for my organization's MDMS
If you are a Quality Manager or similar, and don’t feel confident about ISO 13485:2016, its requirements, and don’t know what an efficient and effective MDMS looks like, this is the Course for you.
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.
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.
I want ISO 13485:2016 Lead Auditor Certification
For an in depth knowledge of the Standard and of Auditing skills. The certification you need if you hope to audit for a Certification Body.
I want to be an MDMS Consultant
Includes a 33-step Path to Certification, a 100+ page ISO 13485:2016 Implementation Handbook. A Documentation Toolkit includes sample SOPs and record forms plus examples of audit schedules, management review agendas. And loads of practical useful hints, tips and materials of real benefit to a new MDMS consultant.
We're certified to the old Standard; I now want to upgrade our MDMS to meet the ISO 13485:2016 requirements.
This Transition Training package includes an ISO 13485:2016 Implementation Handbook, sample paperwork and a Gap Analysis Tool.
I want to implement ISO 13485:2016 for my organization
This Course includes a 33-step Path to Certification, a 100+ page ISO 13485:2016 Implementation Handbook, loads of example SOPs and Forms. And there’s Auditor Certification for yourself.
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.
I'm already an Internal Auditor and I'd like to add ISO 13485:2016 to my auditor certification
With this 8-hour Extension Course you will become a certified ISO 13485:2016 Internal Auditor,
