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- ISO 21001, ISO 29993, and ISO 29994 Accreditation: We've had ISO 21001 accreditation as an Educational Organization with additional e-learning services since 2021. Awarded by BQAI, an accredited Certification Body, our ongoing compliance is confirmed by independent third-party audit every year.
deGRANDSON's ISO 13485 Course Offerings
ISO 13485:2016 (and its EU Harmonized equivalent, EN ISO 13485:2016) is the international management system standard for the manufacture of medical devices. We have courses covering the development, implementation, maintenance, and auditing of these systems.
What is ISO 13485?
ISO 13485:2016, the latest version of the ISO 13485 standard, 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 EU has adopted the current standard as a harmonized standard with the title EN ISO 13485:2016.
EN ISO 13485:2016 is identical to ISO 13485:2016, sometimes called the international version, except for adding 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 Do note that these Annexes are now out-of-date as they do not correspond with the current EU Medical Device Regulations (EU Regulation 2017/725 for medical devices and EU Regulation 2017/726 for in-vitro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 this training mandatory?
Yes and No.
Management Representatives 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?
Just examine this ISO 13485 Courses image map. Click on any course you are interested in to see their individual overviews.
Available ISO 13485 Courses image map. Just click on any course you are interested in to learn more about them.
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deGRANDSON Global is an ISO Certified Educational Organization
In October 2021, we secured certification to three education-related ISO Standards. As a result, we now have a university-grade management system conforming to the requirements of …
We have chosen ISO 21001 certification because it is based on independent third-party assessment, unlike IRCA and Exemplar badges (which we believe are commercially compromised). In addition, it is a ‘university grade’ standard in use globally by schools, colleges, and universities to demonstrate their competence.