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 firstname.lastname@example.org 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 Directors 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