Well known in the industry for our knowledge of device testing and regulatory requirements, ViVitro Labs benefits from extensive experience testing a broad variety of cardiovascular devices in our own laboratory and the feedback received from laboratories and testing facilities all over the world that use ViVitro equipment. Guided by the ISO 5840 standard and FDA guidance document, ViVitro Laboratory Services is a member of both the Standards Council of Canada (SCC) and AAMI. ViVitro personnel are well versed in verification of hydrodynamic performance and assessment of durability testing services for heart valves, transcatheter heart valves, and other cardiovascular devices. Testing is conducted with our own equipment, leveraging decades of apparatus justification by, and familiarity of, regulatory agencies, while providing unlimited resources by our own in-house manufacturing capability. Our Laboratory services are governed by a mature Quality Management System (QMS) that, following GLP principles in an accredited laboratory, certified to ISO/IEC 17025, meet the ISO 5840 standard and FDA guidelines for CE, 510K, IDE or PMA supplements.
ViVitro Labs can offer extensive expertise for product development testing and regulatory submission in areas previously found only in the academic world. Now comprehensive cardiovascular device testing can be offered by a regulatory qualified source in a timely manner that understands your urgency and need for accuracy and credibility with test equipment that is the industry standard.
With several decades of expertise in Cardiovascular Hemodynamics, ViVitro Labs offers the most advanced flow diagnostics capability with our in-house digital particle image velocimetry (DPIV) system. By incorporating DPIV to our suite of services, we can diagnose flow and determine the viability of your cardiovascular device for meeting regulatory standards. ViVitro Labs can also help you avoid problems by providing flow diagnostics as you progress through the various stages of your design development. With a proper understanding of pulsatile flows, fluid dynamics triggers for disease such as shear stresses and turbulent shear stresses can be quantified with a high degree of accuracy. We are well poised to provide you time-resolved, phase-averaged and time-averaged fluid dynamic analysis. Advanced methods such as proper-orthogonal decomposition also allow for capturing the implicit fluid mechanical phenomenon of interest.
Our experts in cardiovascular prosthesis understand the urgency and needs of corporate and regulatory bodies. Our trained personnel will work directly with you to customize testing to meet your requirements. Now, advanced flow diagnostics previously only available in the academic community, is available at ViVitro Labs with the swift turn-around times and regulatory compliance that you require to bring your cardiovascular device to market faster.
of a heart valve
- Knowledgeable testing personnel to support a wide variety of research and regulatory initiatives
- Protocol development to meet Design Verification requirements for CE or FDA submissions
- Active members of AAMI and the Society of Canadian Council and active participants in ISO and other standards boards
- Laboratory following GLP principles and ISO/IEC 17025-compliant for conducting regulatory testing
- Equipment and software manufactured in an ISO 13485 accredited facility
- Rigorous process of verification, validation and testing for software
- Equipment and test methods are validated
- Technical Acumen from prosthetic to transcatheter heart valve and other Class 2 or Class 3 medical devices
- Advanced Flow Visualization collection capability and knowledge to support heart valve replacement, LVAD, TAH, cardiovascular pumps or other devices requiring complex or simplified flow assessment.
Standard Laboratory Services:
- Verification of Hydrodynamic Testing – ISO 5840 Annex L, including Flow Visualization Studies
- Durability Testing – ISO 5840 Annex M
- Various design-specific testing
To enquire about how ViVitro Laboratory Services can help you test your cardiovascular device swiftly while meeting all regulatory requirements, please contact us.