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Anne Marie has been an auditing partner with companies I’ve worked at over the last 6+ years. I have worked with her on a range a different audit types, including full ISO 13485 QMS audits, production specific audits, IEC 62304 software lifecycle audits, medical device design history file audits and supplier process audits. These have covered both high risk and low risk medical devices, from Class I device to Class III devices and covered a range of standards and QMS requirements including 21 CFR 820 requirements. Anne Marie’s professionalism and attention to detail is second to none. Also her understanding of requirements and the process of transferring these requirements into real world medical device Quality Management Systems is extensive. She draws upon her extensive experience in the industry and her years of consulting to provide a thorough audit while also providing welcomed insight on opportunities for improvements. Deliverables have always been on received on time and provide a true, accurate and detailed representation of the area audited.
Caroline Kirwan Director of Regulatory Affairs and Quality at Cumulus NeuroScience Ltd.
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