Services » Consulting

Consulting

ViVitro’s experienced specialists are uniquely qualified to collaborate with you to ensure proficiency of testing methods that meet regulatory requirements for heart valve replacements and other cardiovascular devices. Our team will, aid your cardiovascular device development efforts, help you demonstrate regulatory compliance (including ISO 17025 Accreditation), and help ensure manufacturing quality.  Download an overview of our Technical Services.

ISO 17025 Accreditation

We have successfully assisted our clients in developing various solutions for testing requirements and regulatory submissions. We can serve as either an on-call subject-matter-expert, or as an integral part of your team, allowing you to leverage our experience and knowledge-base for reliable results.

If you seek advice or a partnership for resolving complicated device testing or regulatory affairs issues, ViVitro is happy to provide you with reliable and immediate service. Our goal is not to work as a consultant but rather to provide immediate solutions to challenging problems, or where experience is vital, to drive progress.

Areas of expertise

ViVitro Labs offers consulting services in a variety of critical areas, such as QC systems to assess hydrodynamic performance, laboratory test set-up to assess design development, and requirements for regulatory success. ViVitro Labs is a proven source of expertise and experience in:

  • Prosthetic Heart Valves
  • Heart valve repair devices
  • Cardiovascular devices
  • Verification of Hydrodynamic performance
  • Durability Assessment
  • Flow Visualization (digital particle image velocimetry)
  • ANSI/AAMI/ISO 5840:2005 – Cardiovascular implants – Cardiac valve prosthesis
  • ISO 5840-3:2013 – Heart Valve substitutes implanted by transcatheter techniques
  • ISO/IEC 17025:2005 – General requirements for the competence of testing and calibration laboratories

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