Medical Device Expert Spotlight – Sophie Bell

Medical Device Expert Spotlight

At Test Labs, we believe that our people are our most valuable resource. Their expertise, dedication, and passion are at the heart of everything we do. In this Expert Spotlight, we extend a warm invitation to you to meet Sophie, our Toxicologist, and delve into the wealth of knowledge and experience she brings to the table.

With 8 years of experience in Medical Devices, Sophie holds a Bachelor of Science in Biomedical Science from the University of Sheffield. In her career, she specialised in quality control testing within GLP, GMP, and FDA-accredited settings, gaining expertise in cytotoxicity testing, endotoxin testing, and microbiological quality assessments. As a Senior Study Manager at Test Labs, she focuses on biological evaluation and biocompatibility testing as a GLP study director, bringing extensive regulatory affairs knowledge and experience to her role.

Sophie Bell

Where did you interest in Medical Devices stem from?  

Starting my journey in the medical device industry, I was captivated by discussions among manufacturers about the purpose and creation of these devices. I found satisfaction in the ever-evolving nature of the field, where regulatory updates and technological progression fuel a continuous improvement within these devices. Moreover, knowing that my work directly safeguards the quality and safety of medical devices, supporting patient safety gives me a huge sense of fulfilment.

Have you always wanted to be a toxicologist?

Like many who studied Biomedical Science at University, I had aspirations of becoming a doctor. However, as I progressed through my degree I found my path shifted towards research as my primary interest . Starting as a laboratory technician, I gained crucial experience allowing me to explore various career avenues in life sciences, ultimately discovering my passion for toxicology and medical device regulation. Despite not initially aiming for a career in toxicology, I am grateful for the journey that brought me to this point.

What would your advice to student looking to make it into this industry?

A solid educational background in biological sciences or engineering, such as a degree in biomedical engineering or biology, is essential. Hands-on experience in accredited laboratory settings, as the shift from University Labs to working under a quality management system is quite stark. Experience gained through internships or work experience, helps prepare for the transition to professional environments. The life sciences sector offers opportunities for skill development and exploration, making it an ideal starting point for those without a specific career goal.

What’s your top tip to manufacturers to keep them compliant?

Investing in regulatory compliance as early in device development as possible. Building compliance and safety into a device is easier and more cost effective than having to go back to the drawing board months into the project. If that means bringing in regulatory experience or outsourcing, build the relationships early for best (and fastest) results.

pit stop

Finally……what do you get up to when your not testing and analysing medical devices?

I like to spend much of my free time outdoors on walks or hikes. Not only is it a great way to clear my head but allows me to spend quality time with my dog. I’m an avid reader and have spent much of my life with my nose in a book. I’m also a die-hard Formula 1 fan, and have been lucky enough to attended a couple of races. You’ll find me watching the race most weekend, even if it means getting up at 3-4am and sacrificing a few hours of sleep.

Explore how we can support your medical device journey to the market

Label Durability Validation

We perform assessments of medical device packaging, labels and markings to determine the robustness during the life cycle of the device.

Reusable medical device reprocessing

We test your medical device reprocessing procedures, as detailed in your IFU, validating the cleaning, disinfection and sterilisation cycles.

Disinfection for medical devices

We test the efficacy and compatibility of a wide range of disinfectants for medical devices, including disinfection technologies and robots.

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