A history of innovation, a reputation for excellence

ViVitro Labs is dedicated to supporting the continued innovation of cardiovascular devices such as heart valve replacements, transcatheter valves, LVADs, and stents by providing testing services and equipment of unsurpassed excellence. As a leader in the heart valve testing industry, ViVitro is an active member of AAMI and a participant in several ISO working groups.

Hundreds of cardiovascular device development and research organizations in more than 40 countries around the world trust ViVitro for its expertise, accuracy, and quality. We invite you to explore our website to find out why.

Regulatory and ISO certification that meets the exacting standards of our industry

Quality
ViVitro Labs Laboratory Services in Victoria has been accredited by the American Association for Laboratory Accreditation (A2LA) to perform Laboratory testing for ISO 5840 Cardiovascular Implants – Cardiac Valve Prostheses Annex L and M in accordance with ISO/IEC 17025:2005, the most recognized standard for competence of testing in the industry.

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 products are manufactured in our ISO 13485 facility and meet applicable CE mark directives, achieving the highest standards of quality.

Products that exceed your expectations and stand the test of time

Accuracy
ViVitro Labs testing equipment is a trusted staple for prosthetic heart valve testing in development, research, and educational facilities worldwide. Since our launch of the world’s first and best-selling Pulse Duplicator, ViVitro has set the bar high for accuracy in prosthetic heart valve testing equipment.

• ViVitro Pulse Duplicator: Conduct hydrodynamic testing
• ViVitro SuperPump: Create physiological formed cardiac flow
• ViVitro Hi-Cycle Durability Tester: Assess prosthetic heart valve fatigue/durability
• Vivitro Simulated Use Tester/Transcatheter Trainer: Test transcatheter devices or train with physiological pulsatile flow and pressures
• ViVitro QCTest, ViVitest, HiTest, software applications: ISO 13485 compliant and meets all applicable CE marking directives

Our products have the scope and flexibility to handle your most challenging requirements and can be customized to suit your testing and quality control needs.

Whether you’re building a new lab or upgrading an existing one, rely on ViVitro for equipment that delivers the accuracy and durability that stands the test of time.

Services that harness the force of more than 20 years of experience, a team of 30 engineers, and academic excellence

Expertise
Renowned for its depth of industry expertise, the ViVitro team is your best resource for laboratory testing, engineering services, and development and regulatory consultation.

Laboratory Services: 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.

Engineering: Employing a qualified team of more than thirty multi-disciplinary medical device engineers, ViVitro, helps you meet your Quality Control requirements with customized testing systems, production function testers and QC test and inspection equipment, all manufactured in our ISO 13485 facility.

Consulting: Benefit from a collaborative experience with a team of specialists who have more than 20 years of experience in heart valve development, and PhD credentials and research studies from the acclaimed Advanced Experimental Thermofluid Engineering Research Lab (AEThER). Who better to help you navigate design development, verification testing processes and regulatory approval guidelines?

Ready to talk about your device testing requirements? We’re ready when you are.