New Partnership Brings an Integrated Strategic Approach
In today’s global marketplace for medical devices two of the most important regulatory challenges for manufacturers are obtaining the CE Mark in Europe and complying with FDA requirements in the USA.
Psephos has always been able to bring strategic and practical input into both of these areas, but we are now pleased to announce that we are able to offer even more through our partnering with CardioMed Device Consultants - a USA based medical device consulting company focusing on US regulatory, pre-clinical and clinical studies.
CardioMed is an expanding group of professionals with over 100 years of combined experience working in the field of medical device and combination products development, evaluation, and review. Many of its principal members are former employees of the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). This strategic relationship will enable Psephos Biomedica to offer greater services in the US through our partnership.
For more about CardioMed: www.cardiomedllc.com
This partnership moves Psephos closer to our goal of the global provision of insightful advice and collective experience necessary for the development of medical devices from innovative solutions to the clinical management of significant disease states. Contact Psephos for more information on our services or if you are interested in working with us: firstname.lastname@example.org