ISO 13485 Training on Medical Device Quality Management Systems (MD-QMS) in Ireland

Comply Guru are the first in the world to offer Multi-Accredited ISO 13485 Training in Ireland with the Chartered Quality Institute (CQI), International Registrar of Certificated Auditors (IRCA) and the Regulatory Affairs Professionals Society (RAPS) offering credentials for the Medical Device Industry that are globally recognized.

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.

Comply Guru offer different types of ISO 13485 training courses depending on the target audience and training needs. We can also tailor training to meet your company’s specific needs or requirements. Our courses are available in multiple formats from eLearning, Blended Learning or Instructor-led Learning to help you or your organization master Medical Device Quality Management Systems (MD-QMS) for Regulatory Purposes.

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ISO 13485 Lead Auditor Training for Medical Device Quality Management Systems (MD-QMS)

4.7 ★★★★★ 642 Reviews

ISO 13485 ISO 17021 ISO 19011 Medical Devices

ISO 13485 Lead Auditor Training

40hrs

Price: €1295.00

ISO 13485 Lead Auditor Training 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.

FDA QMSR and ISO 13485 Requirements for Practitioners and Auditors

4.3 ★★★★★ 22 Reviews

FDA QMSR ISO 13485 Medical Devices

FDA QMSR + ISO 13485 Practitioner Training

16hrs

Price: €795.00

FDA QMSR Training is for Practitioners and Auditors 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 (Revised Part 820).

ISO 13485 Internal Auditor Training for Medical Device Quality Management Systems (MD-QMS)

4.6 ★★★★★ 398 Reviews

ISO 13485 ISO 19011 Medical Devices

ISO 13485 Internal Auditor Training

16hrs

Price: €595.00

ISO 13485 Internal Auditor Training 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.

CAPA Practitioner for Medical Devices Training

4.5 ★★★★★ 85 Reviews

CAPA FDA QMSR ISO 13485 Medical Devices

CAPA Practitioner

14hrs

Price: €795.00

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

ISO 13485 Requirements for Practitioners and Auditors

4.5 ★★★★★ 527 Reviews

ISO 13485 Medical Devices

ISO 13485 Requirements Training

10hrs

Price: €495.00

ISO 13485 Requirements Training 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).

ISO 13485 and FDA QSR 21 CFR Part 820 Requirements for Practitioners and Auditors

4.6 ★★★★★ 43 Reviews

FDA QMSR FDA QSR 21 CFR 820 ISO 13485 Medical Devices

ISO 13485 and FDA QSR 21 CFR Part 820 Requirements

12hrs

Price: €495.00

This course is for Practitioners & Auditors who want to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality System Regulation (QSR 21 CFR Part 820).

4.6 ★★★★★ 365 Reviews

ISO 13485 Medical Devices

ISO 13485 Essentials

1.5hrs

Price: €195.00

ISO 13485 Training is for organizations looking for a concise, high-level introduction for their staff.

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