About Us
ViVitro Labs – First in Cardiovascular Device Testing
ViVitro Labs Inc. offers industry-leading cardiovascular test equipment and related testing and consulting services. Since our formation in 1984, we have worked closely with our clients – leading universities, medical device manufacturers and regulatory agencies – to support their research, regulatory and production requirements.
We empower our clients to swiftly and effectively complete world-leading research, and develop high quality, innovative products all while demonstrating regulatory compliance.
Our Clients
ViVitro’s international client base spans the globe and includes the leaders in cardiovascular device research and development in the academic, governmental, and corporate arenas. As the creators of the world’s first commercially available pulse duplicator, ViVitro is recognized as an authority on heart valve replacement and cardiovascular device testing, frequently contracted to provide regulatory testing, advanced engineering solutions, and consulting to those at the forefront of cardiovascular device design. World-renowned laboratories in every continent rely on ViVitro’s testing equipment to ensure accurate results that meet the most rigorous research studies and/or regulatory requirements. We are engaged with the regulatory community to ensure our products and services meet the changing regulatory environment.
Our Products and Services
Laboratory Equipment for Academic Research
ViVitro Labs is the trusted vendor to academic labs worldwide, as evidenced by the hundreds of peer-reviewed publications in which our equipment is cited. The ViVitro Pulse Duplicator was the first on the market and is the world’s best-selling pulse duplicator while the ViVitro SuperPump has become a worldwide standard for the generation of physiological pressure waveforms in academic research applications.
Laboratory Equipment for Industry Research and Development
Large and small heart valve replacement and cardiovascular device companies all over the world rely on ViVitro’s equipment in their research laboratories. Our products are manufactured in an ISO 13485-accredited facility, and meet CE marking directives, easing the burden of compliance for regulatory testing. The academic and industry experience of our staff ensures ViVitro products are developed with an explicit understanding of their purpose.
Close attention to changing industry needs, a commitment to refining and enhancing our products with technological advances, and unparalleled customer service set ViVitro apart and sets its clients up for research and product development success, swiftly and reliably.
ViVitro Labs also provides a variety of product services found in many manufacturer production and QC systems. ViVitro advanced product services include:
- Customized test systems
- Custom production function testers
- Validated standard Function Test Software or customized to meet your needs
- QC test and inspection equipment
Laboratory Services
ViVitro Labs offers testing services following GLP principles in an ISO/IEC 17025-compliant laboratory. Investigations are performed regularly for feasibility and product development to full regulatory submission for CE, 510k, IDE, and PMA supplements of heart valve replacement and cardiovascular devices. The world’s largest companies utilize our services for prompt turnaround and excellent third-party verification to supplement their labs and efforts. Today’s competitive environment requires research and product development efforts to be effective and fast with unsurpassed authority.
ViVitro Labs services include:
- Verification of Hydrodynamic Testing – ISO 5840
- Flow Visualization – ISO 5840
- Durability Testing – ISO 5840
- And other design specific testing
- Protocols can be developed to include ISO and FDA requirements
Our Philosophy:
We recognize that the testing process for heart valve replacements and cardiovascular devices can be one of the most difficult aspects of product development. Employing our knowledge, skill, and vast collective expertise and experience we strive to be first in providing simple solutions to your complex testing challenges.
