ViVitro Labs expands laboratory operations for heart valve testing and devices

The expanded ViVitro Labs capabilities are in compliance with GLP (General Laboratory Practice) requirements, enabling the company to conduct regulatory testing in a fully equipped laboratory environment. Offering Hydrodynamic Assessment and Durability testing utilizing equipment manufactured by our own ISO 13485 compliant facility, ViVitro now enjoys virtually unlimited abilities to determine performance and provide analysis for FDA and ISO5840 requirements.

“I highly recommend the services, technical support, and test equipment from ViVitro Labs, Inc. to anyone needing heart valve device testing capabilities,” said R. E. Phillips, Ph.D., Partner and Vice President of Technology BioStable Science & Engineering, Inc. “I have had personal experience with ViVitro for over fifteen years and found their knowledge of device test requirements and their testing equipment to be superb. Their recent expand

ed emphasis on test equipment/software improvement and methods of device testing only serve to strengthen their place in this focused market for heart valve testing.”

The ViVitro staff actively participates in the American Association of Medical Instruments (AAMI) and International Organization for Standardization (ISO) committees. ViVitro personnel have expertise that includes 20 years of heart valve regulatory testing; including verification and protocols to support regulatory submissions, in addition to a variety of testing methods for all types of research efforts.

ViVitro Labs Inc. offers industry leading prosthetic heart valve test equipment and related testing and consulting services.