Comply Guru Blog

iso 13485

Why does CAPA get a bad rap in the Medical Device Industry?
Eoin Philip Kelly
December 04th, 2024 - Eoin Philip Kelly

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.

As per ISO 13485, is Spreadsheet Validation required?
Eoin Philip Kelly
November 25th, 2024 - Eoin Philip Kelly

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?

Free Webinar on Improving Internal Audit Effectiveness
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.

Internal Auditor or Lead Auditor Training?
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
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