Meet our new Regulatory Consultant, Kate Bandy

Meet Kate Bandy – by Al Mills

Kate joins IMed as Regulatory Consultant on 12th April – so I gave her a brief grilling;

How did you find your way into RA/QA and IMed?

Completely by accident! Having enjoyed working in project management in Higher Education with The Open University for quite a few years, I fancied a change. I saw an opportunity with a medical device product registration team, within a Large Medical Device manufacturer, so I applied. I got the job and took to it straight away. Initially, I was collating technical information for regulatory Global Registration files in areas like SEAPAC and Brazil.

As I gained further experience, I worked on a variety of global submissions and regulatory projects, including legalisation of documents, reviewing elements in commercial contracts and participation in external audits. The Medical RA/QA sector has been a real ‘round peg‘ scenario for me.

And what about your most recent work?

Latterly, I’ve been managing a small regulatory team. We’ve been involved in doing regulatory specs for new product development, MDSAP audit preparation and vigilance activities, such as Field Corrective Action.  And most recently I’ve been focusing on MDR, which has really broadened my knowledge. I enjoy learning and looking at new disciplines that’s one of the reasons I decided to move on to IMed.

So, what is it that you like so much about regulatory work?

I like the way RA is involved across the product lifecycle phases;

1. Design and production of device – working out what needs to be in place for a safe, effective and compliant product
2. Product registrations/CE Marking  – ensuring you can sell it wherever you wish to
3. Post market – surveillance, incident reporting etc – keeping the product safe and working but also acting responsibly, if things don’t go as planned.

These 3 phases come all wrapped up in a Quality Management system, which supports and controls all aspects of design, production and testing. It’s just so interesting to me. I sound like a bit of a nerd, I know! 

What appealed to you about IMed Consultancy?

IMed felt like the right fit for me, because they have lots of experience and they concentrate on high quality advice and investing in strong client relationships. I’m really looking forward to working with a wider variety of medical devices, across a breadth of companies. I want to help clients to achieve their business goals. So, by keeping up to date with all the regulatory deadlines & changes (and other factors like Brexit), I can really support clients as they review exactly where they want to sell their devices, then ensure that it’s possible for them. 

Plus – and for me this is the most important aspect of what we are all doing in the medical device regulatory world – I’d like to see patients benefiting from IMed’s work, supporting safe and effective devices going to market, which could lead to improved recovery rates and quality of life. We can play our part by advising our clients on the regulatory requirements for their device and their responsibilities; then support them in reaching and maintaining those standards.

What’s the next hot emerging area as you see it?

Well, it’s an undeniably exciting time at the moment, so there are a few I could choose, but I am particularly fascinated by the development of wireless technologies within medical devices and how that affects our industry. I’m excited by the opportunities this creates for innovation and the subsequent increasing cybersecurity regulatory requirements; both are areas I’d like to learn more about. 

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

You’ll find me at home in Swansea, probably practicing for bake-off, walking on the beach, or making plans for my August wedding, which I’m really excited about. I do watch a lot of sport though and have been loving the recent 6 Nations coverage. But when it comes to football – I’m actually a committed Arsenal fan!