Blog

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?

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

This insightful blog looks at the practicalities of performing a spreadsheet validation under ISO 13485.

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

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

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.

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.

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.

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.

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.

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.