I'm a biomedical engineer who has been working as a regulatory consultant for the past 10 years specialising in medical device and IVD regulatory and quality affairs in the EU and UK. I have previously led a team of consultants and worked to advance a leading EU Authorised Representative organisation.
I take pride in helping manufacturers get their medical devices to market and have worked with all types of devices including computer aided detection software, active implantable medical devices, pharmacogenomics, cardiovascular devices, and infusion pumps.... Read more