Stuart Baxter

Stuart Baxter is a seasoned professional in the field of regulatory affairs with extensive experience in IVD and medical device sectors. As the Founder, CEO, and Principal Consultant at BaxMed Regulatory Ltd since April 2023, Stuart leads initiatives focused on regulatory compliance. Prior to this role, Stuart served as Regulatory Affairs Manager at LFH Regulatory Limited, specializing in clinical affairs and ISO 13485 quality assurance. Other key positions include consultant roles at Compliance Solutions (Life Sciences) Ltd, and significant experience at Kapitex Healthcare Limited and QIAGEN, where responsibilities encompassed technical file updates, risk management, and international registrations for medical devices. Stuart holds a PGDip in Clinical Microbiology from the University of Nottingham and a BSc in Biosciences & Health from Leeds Beckett University.

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Leeds, United Kingdom

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BaxMed Regulatory Ltd

Consultancy services in the areas of: - Medical Device Regulatory Affairs - In Vitro Diagnostic Regulatory Affairs - Quality Management (ISO 13485:2016) - Risk Management (ISO 14971:2019) - EU, UK, US, APAC, LATAM device registrations - Clinical Affairs - Technical Documentation - Regulatory Strategy - Device Classification - Clinical Evaluation Plan/Report - Performance Evaluation Plan/Report - State of the Art Plan/Report - Analytical Performance Plan/Report - Clinical Performance Plan/Report - Scientific Validity Plan/Report - Biological Evaluation Plan/Report Call or message for more information on services and to arrange a friendly call to discuss the specific needs of your business


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