Caroline Kirwan

Caroline has more than 16 years' experience working within Quality and Regulatory Affairs in the medical device industry. With experience in a variety of technologies, including sensors, cardiovascular and wireless devices, implementing quality systems to ISO 13485:2016, MDSAP and country specific requirements as well as meeting regulatory requirements for approval / clearances worldwide. Caroline was previously a Senior Consultant at Emergo by UL and Manager of Regulatory Affairs and Quality Systems at Stryker Belfast. Caroline has a Bachelor of Science in Biomedical Engineering from Ulster University.