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ISO 13485 Courses

Comply Guru offer courses that provide a more convenient, flexible, and effective way to learn about Quality Management Systems for Regulatory Purposes.

 

ISO 13485 Courses

ISO 13485

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.

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Showing 5 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 2016, in accordance with ISO 19011 and ISO IEC 17021-1.

40 hours Blended Blended CQI & IRCA
€ 1395.00
€ 1595.00

ISO 13485 Internal Auditor Training

This course is for anyone who 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 Blended Blended CQI & IRCA
€ 695.00
€ 795.00

FDA QSR 21 CFR 820 and ISO 13485 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 System Regulation (21 CFR Part 820).

12 hours eLearning eLearning CQI & IRCA

€ 795.00

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 eLearning eLearning CQI & IRCA

€ 595.00

ISO Essentials

Comply Guru offer ISO Essentials Courses for organizations looking for a concise, high-level introduction for their staff.

2 hours eLearning eLearning Comply Guru

 

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CQI & IRCA Accredited Training Provider

CQI & IRCA Accredited Training Provider

Offering certified courses since 2019

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Exemplar Global Recognized Training Provider

Offering certified courses since 2020