Tell us a little about your career path?

I started working in the medical device sector 15 years ago, initially as a development scientist and for more than a decade I have worked in various quality and regulatory roles at start-ups, scale-ups, and multi-national companies.

What is your role at Zedsen, is there a project you’re particularly proud to be part of?

I am the Quality Assurance & Regulatory Affairs (QA/RA) Manager at Zedsen. I have responsibilities for Zedsen complying with the applicable standards and regulations for products/devices that are being developed, supplying compliance oversight. I enjoy being responsible for the implementation of the Zedsen Quality Management System (QMS).

What is your mission?

To ensure the safety and efficacy of products developed by Zedsen, meeting customer and regulatory requirements. I also ensure the suitability, adequacy, and effectiveness of the QMS.

Based on your experience, what advice would you give to staff in similar roles?

Never compromise on compliance but make sure your processes are suitable for the size of the organisation. If it starts to feel like the standards and regulations are getting overwhelming, always bring in back to risk to the product or process. My role requires project management, in my experience most issues can be resolved by making sure there are clear roles & responsibilities, communication and deliverables.

What do you like about Zedsen? What would you say to someone thinking of joining the Zedsen team?

The application of the Zedsen IP/technology has the potential to make a significant improvement to the health of patients and society at large. The current size of the company and stage in product development means you can personally make a real impact. It also allows you to get to exposure and to collaborate with other departments. Based on this it’s an amazing opportunity for anyone thinking of joining the team.

How do you see the landscape of healthcare changing over the next ten years?

From a regulatory perspective there are global changes already in progress. There has been the introduction of the MDR/IVDR within the EU, the UK are looking at their own medical device regulations and the FDA (Food and Drug Administration) has proposed to align/harmonise with ISO 13485:2016 in the future.

In terms of specific technology, I think Artificial Intelligence and Machine Learning will become more important over the next 10 years. As with any emerging technology the challenge is for the regulations to keep pace with innovation.

What should medical technologist read, see, or listen to?

I personally enjoy listening to the Freakonomics podcast, even when the topic is not specifically related to medicine and healthcare it’s useful to understand socioeconomic factors that influence companies and projects in general. I find posts by Michelle Lott, RAC on LinkedIn helpful, there is a lot of practical, pragmatic. and common-sense information and advice which mirrors my own approach to QA/RA.