Test Labs - Medical Devices
Sophie Bell is a skilled professional in the field of regulatory affairs and study management, currently serving as a Senior Study Manager at Test Labs - Medical Devices since March 2024. Prior to this role, Sophie held the position of IVD & Cosmetic Regulatory Affairs Manager at Patient Guard from October 2021 to March 2024 and previously worked as a Regulatory Affairs Officer. Sophie's early career at Wickham Laboratories Limited spanned from April 2016 to November 2021, where Sophie advanced to the role of Head Of Section. Sophie Bell completed a Bachelor of Science in Biomedical Sciences at The University of Sheffield from 2012 to 2015.
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Test Labs - Medical Devices
Test Labs is a boutique medical device contract research organisation with accredited Quality Management Systems. We work with medical device manufacturers providing expertise in clinical evaluation and reprocessing validation providing clients with tailored, highly customised solutions. In an ever-changing world where maintaining the status quo is not enough, we've pioneered a faster, agile approach to research. We provide an end-to-end project consultancy where chemistry, microbiology and material sciences are all under one roof. Our dedicated team offers undivided attention, providing clients with intelligent insights enabling them to make the right decisions, save money and ultimately, save a patient's life. We have three state of the art testing chambers which are fully sealed and equipped with sensors to monitor a range of different parameters including temperature and humidity. These chambers allow us to recreate environments with a variety of conditions to stimulate real-life challenges when testing products. The microbiology area is fully equipped to perform a variety of tests ranging from disinfectant and technology efficacy to bioburden and environmental monitoring. We have vast experience in method transfer and validation which we use to create bespoke investigation of products to meet regulatory requirements. Our material science capabilities were purposely built to provide testing which assesses for any potential material damages due to processes completed throughout the lifecycle of the product. We perform both quantitative and qualitative methods using calibrated equipment to check for visual, chemical and physical changes. The Chemistry area is equipped to perform a range of tests, including testing concentrations of solutions, formulation development and calibration of reference gases. We work closely together to develop customised study plans which leverage knowledge of different scientific fields to meet the needs of our customers.