Where are you from?   

Originally from Northwest England, the Wirral. 

What did you want to be when you grew up?   

I thought I’d be a GP. 

So how did you find your way into Medical Device Regulatory?   

Via software, business analysis, project management, process improvement, then setting up a Quality Management System for a medical device manufacturer. 

Why does QA/RA interest you?   

From my first job on a project to deliver software to support sales and marketing, I got interested in ways to do things better.  That first step set the direction for much of the rest of my career, including quality.  Then when the company I was working for, my first medical device manufacturer, asked me to build and certify their QMS, I naturally picked up the regulatory work in addition to the quality pieces. 

What about your career so far? 

It’s always been interesting.  I’ve been involved in such a wide range of different medical devices and IVDs for different conditions, using varied technologies, manufacturing processes etc.  Regulations and standards change, software is playing an ever-increasing role in medical devices and IVDs and we are seeing more and more Software as a Medical Device (SaMD), including devices using Artificial Intelligence.  So I’ve seen lots of changes and had to master them. Over the last couple of years, I’ve enjoyed getting a lot more experience of FDA submissions under the US regulatory system. 

And your most recent work? 

I’ve been working with SaMD manufacturers; assisting them with their regulated software processes and with ensuring their Clinical Evaluations meet the expected standard.  It’s often the case that Quality and Software Engineers talk different languages, so there can be mutual incomprehension, leading to too much or too little control. 

What appealed to you about this consulting role and IMed? 

The IMed team were so friendly, with so much knowledge and experience.  IMed seems the perfect way to get exposure to different projects, whilst having a back-up system and colleagues with whom to talk over the trickier issues and share the wins. I love working in a Team and I felt like IMed was a good fit for me. 

What would you say are the key regulatory challenges for Med Dev companies currently? 

In Europe, access to Notified Bodies has obviously become a real issue for manufacturers of devices and IVDs.  The issue is particularly acute for IVD manufacturers, as a number of issues, including Covid, have meant that too few Notified Bodies have been certified for different types of IVDs; so there’s a large backlog.  There is also a long-standing issue with lack of skilled resource to support regulatory activity at all points in the industry. But I can help more of them now I’m part of the IMed Team! 

And when you’re not delving into regulatory detail, where can we find you? 

I’ve just adopted a ‘Little Sister’ as part of the Big Brother, Big Sister program running in Oxford, where I live (www.oxfordhub.org/bbbs).  So right now, I’m spending a lot of time at Hinksey lido with her.  I also enjoy yoga, cycling, walking, singing and anything chocolate-related. 

That’s amazing Rachel- what a great initiative! How did that come about? 

I’d heard about Big Brothers, Big Sisters (BBBS) when I lived in the US for 4 years. I don’t have children but get on well with my friends’ and live in a deprived area of Oxford. I decided I wanted to do some volunteering with kids, investigated different options and signed up to BBBS, who now have initiatives in the UK and also with some after-school tuition of local secondary school pupils, once a week. BBBS is a lot of fun and I get a lot out of it – as much as my ‘sister’, I’d say. I was teaching her and her nearest sibling to ride their bikes last week – hilarious. 

And is there anything else interesting about Rachel Gauntlett that we really should know? 

I have an MSc in Artificial Intelligence, speak French after a year in the Erasmus exchange during my degree and I spent 4yrs living and working in Atlanta, Georgia during the Noughties. I also enjoy yoga, cycling, walking, singing and anything chocolate-related. 

And I happen to know you also like dogs ……even if you don’t have one yourself. So, not mentioning your extensive and valuable QA/RA experience ( which we intend to put to very good use )  with your interests in mentoring, animals AND chocolate, there’s no question that you are going to fit right in at IMed. Welcome to the Team!