well worth a re-read of their website or for those who haven't to understand the significance of this company ... they are not sitting in the background waiting for us to finish our trials
http://experiengroup.com
We are accomplished strategists who work with all entities of the medical device industry. From policy to project considerations, we produce concrete successes for our clients. We support due diligence activities, perform strategic reviews and lead companies’ interface with regulators, investors and industry partners.
Medical device expertise
We embrace technology. We have been actively involved with FDA’s Innovation Pathway programs from the start and have helped commercialize paradigm-changing devices to improve patient care. Our clients’ products encompass all major areas of clinical practice. The technologies we support include traditional medical devices and IVDs, software-only devices and combination products (devices with drug and/or biologic elements).
We are involved with most every area of clinical practice, supporting diagnostic, monitoring and/or therapy devices. We work closely with the various CDRH Divisions during premarket review to ensure meaningful communications regarding appropriate device testing. We support Notified Body selection for our clients to ensure proper understanding of the clinical need addressed by the technology. We work closely with health care professionals—as investigators, scientific advisors and entrepreneurs to improve patient care. Our team regularly attends physician society conferences to remain abreast of industry advancements
Results speak for themselves. We maintain exceptional clearance and approval rates for our clients’ U.S. and OUS premarket applications. We manage multiple submissions and lead numerous audits each and every month, covering a wide array of technologies. Our clients’ outcomes serve as our performance metric."
