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Corrective and preventive action blog image - comply guru ireland
Michelle Keane
December 04th, 2024 - Michelle Keane

Why does CAPA get a bad rap in the Medical Device Industry?

Michelle Keane discusses CAPA in Medical Devices including potential reasons organizations struggle and the FDA raise so many findings in this area.

Iso 13485 and spreadsheet validation - comply guru ireland
Michelle Keane
November 25th, 2024 - Michelle Keane

As per ISO 13485, is Spreadsheet Validation required?

As per ISO 13485, is it true or false that a medical device organization that uses spreadsheets is only required to validate spreadsheets that contain calculations?

Comply guru team at global access 2024 - comply guru ireland
Eoin Philip Kelly
November 09th, 2024 - Eoin Philip Kelly

Comply Guru Sponsors Global Access 2024

Comply Guru proudly sponsored Global Access 2024 which is Ireland’s largest conference for Quality and Regulatory Affairs Professionals in Medical Devices.

Webinar on improving internal audit effectiveness 28-november-2023 landscape - comply guru ireland
Eoin Philip Kelly
November 14th, 2023 - Eoin Philip Kelly

Free Webinar on Improving Internal Audit Effectiveness

Join us on Tuesday, November 28th for a free Webinar on Improving Internal Audit Effectiveness with John Collins from 3-4pm GMT.

Irca certified iso 14001 and iso 45001 lead auditor training approval - comply guru ireland
Eoin Philip Kelly
November 07th, 2023 - Eoin Philip Kelly

New IRCA 2-in-1 Approval for EHS Lead Auditors

On 30th October 2023, IRCA formally certified Comply Guru’s latest Blended Learning offering, a Combined ISO 14001 and ISO 45001 Lead Auditor Training (No. 2677) that is a hybrid of eLearning and Live Workshops.

New partnership with clinius oy in finland - comply guru ireland
Eoin Philip Kelly
August 28th, 2023 - Eoin Philip Kelly

New Partnership with Clinius Oy in Finland

Comply Guru is excited to announce a new strategic partnership with Clinius Oy in Finland, a pioneer in clinical device trials who are a device CRO specializing in clinical device studies, product documentation and quality systems for the Medical Device Industry.

Comply guru's new website launches - comply guru ireland
Eoin Philip Kelly
July 03rd, 2023 - Eoin Philip Kelly

Comply Guru’s New Website Launches

Today I am proud to announce our new & improved website for Ireland, UK and the U.S is now live! I have personally managed this project as I sought to make various improvements across the entire website.

Eu mdr and five challenges - comply guru ireland
Eoin Philip Kelly
June 29th, 2023 - Eoin Philip Kelly

EU MDR and Five Challenges

While the EU Medical Device Regulation (MDR) brings numerous improvements, it also poses several challenges that need to be addressed. In this blog, I discuss five of the challenges under the European Medical Device Regulation.

Internal auditor or lead auditor training? - comply guru ireland
Eoin Philip Kelly
June 02nd, 2023 - Eoin Philip Kelly

Internal Auditor or Lead Auditor Training?

One of the most common questions I am asked relates to whether internal auditor or lead auditor training is the right choice. The answer is it depends on several factors. Let’s discuss.

Benefits of blended learning - comply guru ireland
Eoin Philip Kelly
May 24th, 2023 - Eoin Philip Kelly

Benefits of Blended Learning

Let’s talk about Blended Learning. In 2019, Comply Guru set out to create a new approach to conventional Auditor Training, launching it’s first CQI & IRCA Accredited Blended ISO 9001 Internal Auditor Training Course (No. 2149) in March of the same year.

CQI & IRCA Approved Training Provider

CQI & IRCA Approved Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020