Blog

Michelle discusses the recent affirmation of ISO 13485:2016 and shares her insights on the new guidance reflecting a Global Regulatory Evolution.

Michelle discusses why ISO 13485 and ISO 14971 make a critical clarification on Risk, and clarifies a dangerous misconception in medical device development.

Borderline products remain one of the trickiest challenges under the EU Medical Device Regulation (EU) MDR 2017/745 and the In Vitro Diagnostic Regulation (EU) IVDR 2017/746.

Comply Guru is now an Approved Provider with the Regulatory Affairs Professionals Society (RAPS) offering more recognition for our Medical Device Training.

Eoin discusses the exciting new courses Comply Guru has launched in 2025 for QARA Professionals within MedTech.

This blog discusses the current status of the role of the PRRC sharing key takeaways from a free webinar Comply Guru ran and is available on demand on our website.

In a recent poll, the majority wanted Michelle to discuss Training and Competence, Clause 6.2 of ISO 13485. In this blog, she shares her thoughts.

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

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 it true or false that a medical device organization that uses spreadsheets is only required to validate spreadsheets that contain calculations?

Comply Guru proudly sponsored Global Access 2024 which is ‘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 GMT.

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 , 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.