DENVER, CO – Now medical device compliance officers
and quality assurance teams will have reliable access to competitive predicate
device samples required for FDA product clearance, thanks to the newly launched
INBETWEEN Testing Alliance™. A privately held company founded by three seasoned
medical device and healthcare professionals, INBETWEEN is focused solely on
facilitating the acquisition of competitive predicate test samples and
documenting their chain of custody.
Historically, the procurement of competitive samples has too often been
left to unconventional means, a practice no longer acceptable in an industry
subject to ever-increasing compliance requirements for safety and quality.
Barbara Anschutz, President and Founder of INBETWEEN Testing
Alliance said, “We offer a service that has never existed before in the medical
device industry but is long overdue. Gone are the days of device companies
having to use back channels to obtain the competitive test samples they need to
complete testing required by the Food and Drug Administration for a product
clearance. In the face of increasing industry compliance concerns, any
corporate compliance officer should want their company to be a member of the Alliance.”
Participating in the Alliance
reduces risk by assuring the quality of samples and avoiding costly delays. For
a limited time, device manufacturers may become charter members of the
INBETWEEN Testing Alliance at a reduced rate by completing a membership form at
www.inbetweenta.com. The
inaugural membership drive ends March 1, 2012. Call 303.587.2847 or email greg.olson@inbetweenta.com
for more information.
Denver-based INBETWEEN Testing Alliance was founded in 2011
to help members acquire predicate device testing samples to meet FDA and USDA
requirements for spine, orthopedic, trauma, clinical diagnostic,
cardiovascular/thoracic, dental, respiratory, vascular, veterinary, wound
treatment, auditory, temperature management, perfusion and other specialty
device product clearance. The company operates under a Medical Director’s
license and meets all FDA and USDA requirements as distributors and relabelers
of product for both mechanical and animal testing. Their auditable quality
system ensures their chain-of-custody documentation is validated and verifiable.
Posted by Sean Fenske, Editor-in-Chief, MDT