ISO 13485 Lead Auditor Training
This course is 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.
Comply Guru offer Medical Device QARA Training that is available in multiple formats from eLearning, Blended Learning or Instructor-led Learning to help you or your organization.
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Training Guide
This course is 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.
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This course will provide learners with the knowledge and skills required to perform audits of medical device quality management systems (MD-QMS) against the European Union’s Medical Device Regulation (EU 2017/745) in accordance with ISO 19011 and ISO 17021 as applicable.
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This online course takes you through the new European Medical Device Regulation (2017/745), not just from an industry perspective, but also from a Notified Body perspective. It has been specifically designed for Quality & Regulatory Professionals who are new to the Regulation.
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This course takes you through the new , not just from an industry perspective, but also from a Notified Body perspective. It has been specifically designed for Quality & Regulatory Professionals who are new to the Regulation.
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This course provides learners with the knowledge and skills required to understand and complete an audit against the IMDRF Medical Device Single Audit Program (MDSAP) for medical device quality management based on ISO 13485 and international regulatory bodies medical device regulations.
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This course is 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.
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This course is for anyone who wants to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality Management System Regulation (21 CFR Part 820).
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This course provides clarity on the role and responsibilities of the Person Responsible for Regulatory Compliance (PRRC) introduced under Article 15 of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
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This course provides a comprehensive overview of the international standard for risk management for medical devices, ISO 14971. It has been specifically designed for Quality & Regulatory Professionals in the Medical Device Industry.
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This course is 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).
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This course provides learners with the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) and the MDSAP audit approach.
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Comply Guru offer a European Medical Device Regulation (EU MDR 2017/745) Essentials Course for organizations looking for a concise, high-level introduction for their staff.
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Comply Guru offer a European In Vitro Diagnostic Regulation (EU IVDR 2017/746) Essentials Course for organizations looking for a concise, high-level introduction for their staff.
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Comply Guru offer an ISO 13485 Essentials Course based on ISO 13485 for organizations looking for a concise, high-level introduction for their staff.
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This course covers CAPA requirements, common root cause investigation tools, and how to prepare for an inspection of the CAPA process.
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This course is for anyone that wants refresh or enhance their ability to complete internal audits of part of their Management System (MS) whether its against ISO 9001, ISO 13485, ISO 14001, ISO 45001 or ISO 17025.
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This course is for anyone that wants to understand the principles and practices of conducting management system audits in accordance with ISO 19011 (2018).
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