Established in January 2003, CardioMed Device Consultants is an expanding group of professionals with over 100 years of combined experience working in the field of medical device development, evaluation, and review. Many of our principal members are former employees of the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). They have had integral roles in the review of medical device marketing applications and regulatory submissions, the development of FDA guidance documents, FDA policies, and both U.S. and international voluntary performance standards. They are dynamic individuals with extensive ties throughout CDRH and the medical device industry. Each individual has his/her own area of device expertise; however, their education, experience, and broad knowledge of FDA’s processes and requirements often prove valuable for manufacturers of medical devices intended for other specialty areas.
In addition, CardioMed Device Consultants has incorporated an expanding group of Affiliate and Clinical Services Consultants with extensive experience in regulatory affairs and quality assurance from an industry perspective. This addition gives CardioMed Device Consultants a full spectrum team of professionals fully capable of addressing the multitude of needs of the medical device and related industries.