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Reaffirmed, Not Static: ISO 13485 and the Global Regulatory Evolution
Michelle discusses the recent affirmation of ISO 13485:2016 and shares her insights on the new guidance reflecting a Global Regulatory Evolution.
Low Risk Does Not Mean No Risk
Michelle discusses why ISO 13485 and ISO 14971 make a critical clarification on Risk, and clarifies a dangerous misconception in medical device development.
MDCG Manual on Borderline and Classification (Version 4)
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 Gains RAPS Approved Provider Status
Comply Guru is now an Approved Provider with the Regulatory Affairs Professionals Society (RAPS) offering more recognition for our Medical Device Training.
New Courses to Reach New Heights in 2025
Eoin discusses the exciting new courses Comply Guru has launched in 2025 for QARA Professionals within MedTech.
The Role of the PRRC Part 1
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.
Training and Competence under ISO 13485
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.
Practicalities of performing Spreadsheet Validation
This insightful blog looks at the practicalities of performing a spreadsheet validation under ISO 13485.
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?
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?
