Online Medical Device Quality & Regulatory Training

European Medical Device Regulation (EU MDR 2017/745) Training that takes you through the new EU MDR 2017/745, not just from an industry perspective, but also from a Notified Body perspective. This course has been specifically designed for Quality & Regulatory Professionals.

ISO 13485 Lead Auditor Training for anyone that wants to gain the knowledge and skills required to perform full system first, second and third-party audits based on ISO 13485, in accordance with ISO 19011 and ISO IEC 17021-1.

ISO 13485 Internal Auditor Training for anyone that wants to be part of the team that performs internal audits of part of their Quality Management System (QMS) based on ISO 13485.

ISO 14971 Training that provides a comprehensive overview of the international standard for risk management for medical devices. This course has been specifically designed for Quality & Regulatory Professionals in the Medical Device Industry.

This ISO 13485 & FDA QSR 21 CFR Part 820 Training that covers the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality System Regulation (21 CFR Part 820).

ISO 13485 Foundation Training for anyone looking to gain a comprehensive understanding of the core requirements of ISO 13485 and this highly interactive course can be completed anytime, anywhere (24/7).

European In Vitro Diagnostic Regulation (EU IVDR 2017/746) Training that takes you through the new EU IVDR 2017/746, not just from an industry perspective, but also from a Notified Body perspective. This course has been specifically designed for Quality & Regulatory Professionals.

MDSAP Requirements & Auditor Foundation Training that provides learners with the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) and the MDSAP audit approach.

This ISO 13485 Essentials eLearning Course offers a short, high-level overview of ISO 13485 for those who seek a highly interactive way to learn at a time & a pace that works best for them.

This European Medical Device Regulation (EU MDR 2017/745) Essentials eLearning Course is for anyone working in the medical device industry sector who is looking for a concise, high-level introduction to the EU MDR.

This European In Vitro Diagnostic Regulation (EU IVDR 2017/746) Essentials eLearning Course is for anyone working in the diagnostics sector who is looking for a concise, high-level introduction to the EU IVDR.