First in Cardiovascular Testing Services
Widely recognized as the authority on regulatory requirements and advanced cardiovascular device testing techniques, ViVitro’s reputation is well earned. From the depth and breadth of staff experience to the preponderance of ViVitro testing equipment that is found in preeminent labs worldwide, ViVitro enjoys an unmatched wealth of knowledge, experience, trust, and skill to assist you in demonstrating safety and efficacy for regulatory approval, swiftly bringing your device to market.
Comprehensive laboratory services previously only found in academia are now available to you. ViVitro Labs is governed by a mature Quality Management System (QMS) that, following GLP principles in an accredited laboratory that is certified to ISO/IEC 17025, meets the ISO 5840 standard and FDA guidelines. ViVitro Laboratory Services are engaged worldwide for heart valve testing, transcatheter heart valve testing, heart valve durability or fatigue testing, and heart valve hydrodynamic testing, and have been used for regulatory approvals for over 25 years. For those that require the utmost in testing accuracy and regulatory familiarity and compliance, ViVitro is renowned for its proven success from product development testing to full regulatory submission of Class 2 or Class 3 medical devices. Test your cardiovascular device with a regulatory qualified source that understands your urgency and need for accuracy. Learn more
Advanced engineering services that empower you with a qualified team of more than thirty multi-disciplinary medical device engineers is not something you find at most device testing equipment facilities. Fortunately, ViVitro can exceed your expectations, offering our clients access to professionals with acute expertise in mechanical design, electronics, and software engineering. Should you require function-testing or other quality systems or equipment, ViVitro would be pleased to help you meet your Quality Control (QC) requirements with customized testing systems, production function testers and QC test and inspection equipment, all manufactured in our ISO 13485 facility. Learn more
Consulting services that draw from deep academic research and extensive industry experience are rare. ViVitro’s consulting clients benefit from a collaborative experience with specialists who are uniquely qualified to navigate the design development and verification testing processes and regulatory approval guidelines for cardiovascular devices. Active members of AAMI and participants of ISO working groups, the ViVitro team is an integral part of the cardiovascular community, while ViVitro’s Director of Laboratory Services holds PhD credentials and research studies from the acclaimed Advanced Experimental Thermofluid Engineering Research Lab (AEThER). You simply will not find a more powerful partner to help you achieve success. Learn more
Knowledge, experience, trust, and skill…ViVitro’s significant and varied strengths offer you a simple solution to your complex cardiovascular device testing requirements. Contact us now to discuss how we can address the testing and regulatory approval processes for your current project.