Software Regulations & Standards Training

Software Regulations and Standards Training to help your Quality, Regulatory Affairs or Developer Team.

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2025 Training Guide

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

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CQI & IRCA Approved Training Provider

CQI & IRCA Approved Training Provider

Offering certified courses since 2019

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Exemplar Global Recognized Training Provider

Offering certified courses since 2020