Connect With Us
Describe your need or issue with us and a Kinexum representative will be in touch with you shortly to discuss how we might be able to assist you.
Gina has over 25 years of experience developing US and international regulatory strategies and submissions and assisting in quality management activities for global medical devices companies of various sizes. Her medical device experience includes cardiac mapping devices, endoscopes and related accessories, speech pathology devices, peripheral vascular devices and active implantable devices for treatment of congestive heart failure, hypertension, GERD and diabetes. Prior to founding GMC Regulatory Strategies in 2019 she worked as VP of Regulatory and Quality for several medical device companies and was responsible for all US and EU regulatory strategy, management of regulatory staff and completion of all regulatory submissions and tasks. Gina has extensive experience preparing EU technical files and US submissions (IDE, PMA, premarket notifications, pre-submissions and breakthrough designations).