Medical Device Quality Assurance & Regulatory Training

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

Comply Guru Training Guide 2024
Showing 22 Courses

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.

40 hours CQI & IRCA Exemplar Global

$ 1595.00

EU MDR Auditor Training

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.

24 hours Exemplar Global

$ 1495.00

EU MDR Training for Practitioners

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.

20 hours CQI & IRCA Exemplar Global

$ 1195.00

EU IVDR Training for Practitioners

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.

18 hours Exemplar Global

$ 1195.00

MDSAP Auditor Skills Training

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.

16 hours Exemplar Global

$ 1195.00

ISO 13485 Internal Auditor Training

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.

16 hours Exemplar Global

$ 895.00

FDA QMSR + ISO 13485 Foundation Training

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).

12 hours CQI & IRCA Exemplar Global

$ 795.00

ISO 14971 Foundation Training

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.

8 hours CQI & IRCA Exemplar Global

$ 695.00

ISO 13485 Foundation Training

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).

8 hours CQI & IRCA Exemplar Global

$ 695.00

MDSAP Auditor Foundation Training

This course provides learners with the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) and the MDSAP audit approach.

8 hours Exemplar Global

$ 695.00

EU MDR 2017/745 Essentials

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.

2 hours Comply Guru

$ 395.00

EU IVDR 2017/746 Essentials

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.

2 hours Comply Guru

$ 395.00

ISO 13485 Essentials

Comply Guru offer an ISO 13485 Essentials Course based on ISO 13485 for organizations looking for a concise, high-level introduction for their staff.

2 hours Comply Guru

$ 295.00

Medical Device CAPA and Root Cause Investigation Training

This course covers CAPA requirements, common root cause investigation tools, and how to prepare for an inspection of the CAPA process.

16 hours Comply Guru

 

Internal Auditor Refresher Training

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.

7 hours Exemplar Global

 

ISO 19011 Auditing Competency Training

This course is for anyone that wants to understand the principles and practices of conducting management system audits in accordance with ISO 19011 (2018).

16 hours Exemplar Global

 

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CQI & IRCA Accredited Training Provider

CQI & IRCA Accredited Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020