What is ISO 13485?
ISO 13485 is an internationally-recognized standard that sets out the requirement for a Medical Device Management System (MDMS).
It was initially published in 1996 as ISO 13485:1996 and revised in 2003. Associated standards since replaced by ISO 13485 include ISO 13488, EN 46001 and EN 46002. The current standard has been adopted by the EU as a harmonized standard with the title EN ISO 13485:2016.
EN ISO 13485:2016 is identical with ISO 13485:2016, sometimes referred to as the international version, except for the addition of 3 Annexes related to EU Directives. Do note that these Annexes are now out-of-date as they do not correspond with the current EU Medical Device Regulations (EU Regulation 2017/725 for medical devices and EU Regulation 2017/726 for in-vitro medical devices).
What is ISO 13485 Training?
ISO 13485 involves training programs designed to equip auditors, lead implementers, quality managers, and other management system professionals with the necessary skills and knowledge to develop, implement, maintain, or audit Medical Device Management Systems and ensure their compliance with the requirements of ISO 13485.
Is ISO 13485 Training Mandatory?
Yes and No.
Management Representative or other professionals with day-to-day responsibility in maintaining an MDMS are not required to undergo ISO 13485 training. It is instead implied as already part of developing competence. It is not a specific stand-alone requirement.
That said, ISO 13485 training is strongly recommended as effective internal audits are essential to doing a professional job in maintaining your Medical Device Management System and preparing it for Certification Body audits.
How Can I Enroll in an ISO 13485 Training Course?
You can enroll in any of deGRANDSON’s online training courses by going to the product page of the course you want to enroll in. Once there, add the course to your cart and then proceed to checkout and payment.
Once you’ve paid for the course, you will be asked to provide the email address or addresses of the people who will be enrolling in the course. They will then receive an email providing the username and password they would need to access deGRANDSON’s Learning Management System where the training is delivered.
Please see this video to see a more visual demonstration of the enrollment process.
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