Mark how did you get into Quality and Regulatory Affairs?

After graduating with qualifications in Microbiology (BSc) and Bioinformatics (MSc) from University College Cork, I completed a course in Quality Assurance at the Cork Training Centre and as part of that course there was a work experience placement. My placement was with a start-up medical device company that was in the early stages of implementing a Quality Management System and developing a regulatory strategy to get their new medical device CE marked. After the placement ended, I was kept on as a Quality Engineer and worked with experienced QA/RA consultants to ensure readiness for the company’s initial certification audits and file reviews. I think I was very fortunate to get my start in Medical Device QA/RA in a start-up as it gave me exposure to all aspects of Quality Management Systems and applicable regulatory requirements, whereas gaining such a broad level of experience from an entry level position in a multinational medical devices company would be much less likely.

Where do you see the greatest challenges in Medical Devices QA/RA over the next 5 years as OrthoXel expands commercially?

All medical device firms that market or plan on marketing their devices in the EU must navigate the EU’s new Medical Device Regulation which has upped the ante significantly compared to the Medical Devices Directive, for instance, by imposing stricter requirements for claiming equivalency to an existing CE-marked device in the absence of having clinical data from pre-market clinical studies. Another important challenge companies face will be getting Technical File reviews for CE-mark approval in a timely manner due to a significant reduction in the numbers of notified bodies certifying to MDR requirements and growing demand for those remaining.

Outside of your demanding and detailed role what do you enjoy spending your free time on?

Walking, reading and playing an occasional game of pool with friends.