Medical Device Expert Spotlight – Toni Carlton

Medical Device Expert Spotlight

At Test Labs, our greatest strength lies in our people – their expertise, dedication, and passion form the backbone of our success. In this edition of Expert Spotlight, we are proud to introduce Toni Carlton, our Head of Quality and Compliance. Toni’s extensive experience and commitment to excellence have been instrumental in achieving our recent Good Laboratory Practice (GLP) certification.

Toni brings a wealth of knowledge to our team, backed by a decade of experience in UKAS accredited laboratories. Her journey began in the NHS, where she worked in an ISO 15189 accredited clinical biochemistry department. She holds a Bachelor of Science degree in Applied Biomedical Science from the University of Westminster and is a HCPC registered biomedical scientist. Toni’s career has been marked by a strong focus on quality assurance, encompassing quality control, validation, and the implementation of new processes.

We invite you to learn more about Toni and the expertise she brings to Test Labs.

What do you do at Test Labs?

As Head of Quality and Compliance at Test Labs, my primary responsibility is to ensure that all the processes and procedures are administrated and maintained to the highest standards. My role has several key functions, including quality assurance, regulatory compliance, risk management, training and performance monitoring. Compliance is crucial at Test Labs to ensure testing meets our customer needs, so most recently my role has been focusing on implementing procedures to meet the requirements of GLP and coordinating with the MHRA to gain certification.

Where did your interest in science stem from?

My interest in science has been present for as long as I can remember. As a child, I remember having one of those microscope kits and being excited to look at slides of onion cells and insect wings. Throughout school, Science and Math were always my strongest subjects, which made them really easy for me to enjoy. As I grew older, my fascination with Science deepened, leading me to seek a career in Science where I could help people, without needing to be in a directly people-facing role.

Have you always wanted to work in Compliance?

No, I didn’t originally plan on this career path. I wanted to be a forensic scientist, but when I realized how difficult it was to enter that field, I took a job in the pathology department at a hospital, which led me to become a biomedical scientist. Working closely with my quality manager on method validation, audits, and quality control sparked my interest in compliance, and now I’m grateful to leverage these skills at Test Labs.

What would your advice be for someone thinking of getting into Compliance?

Entering the compliance field demands a blend of education, experience, and commitment. A strong educational background, not just in compliance but also in your specific field, is crucial. Compliance is dynamic, with constantly evolving regulations, so adaptability and a willingness to continuously learn are essential for long-term success.

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

Start with a solid risk-benefit analysis, as it forms the foundation for a product’s entire lifecycle. Map out all device and regulatory requirements, evaluate risks and hazards, and identify existing risk controls to uncover and address any gaps. Embedding this analysis into development and lifecycle management enhances compliance, patient safety, and product quality for medical device manufacturers.

What do you love most about your job?

I love that my job fulfils my career goal of finding a job where I feel like I am helping people without being people-facing. Knowing that my role and the work the team do has a positive impact on the industry and ultimately leads to the safety and reliability of medical devices being used on patients is immensely rewarding.

What do you get up to when you’re not auditing and maintaining the systems at Test Labs?

Between having an extension done on the house and planning our wedding, there hasn’t been much time for anything else lately. I enjoy DIY projects and getting hands-on, so it’s been great to get stuck in. However, when I need a break, I’m likely binge-watching the latest release or the same films over and over again.

My weekends usually consist of watching or attending some form of sport whether that is football, cricket, boxing or Formula 1. I love having something to look forward to, so I am constantly searching for the next event to attend, or the next destination to book.