Accredited ISO 5840 and 17025 Testing Services

Save time and build regulatory confidence with independent ISO 5840 and 17025 results from ViVitro Labs based in Victoria Canada and Marseilles France.

Durability Testing

Hydrodynamic Testing

Customized-testing

Customized Testing

Our laboratory testing services are accredited by the American Association for Laboratory Accreditation (A2LA) in Canada and Le Comité Français d’Accréditation (Cofrac) in France. They are based on ISO 5840.

ViVitro Labs in Victoria Canada holds ISO/IEC 17025:2005 accreditation for: Cardiovascular Implants – Cardiac Valve Prostheses.

  • Durability Testing
  • Pulsatile-Flow Testing
  • Steady Flow Testing

ViVitro Labs is a member of the ISO 5840 standards committee and is actively engaged in developing testing standards to assist in regulatory submission. ViVitro Labs ensures that test protocols will meet evolving regulatory requirements. Read our Guide to ISO 5840 Testing.

Cardiovascular Device Testing

For new classes of cardiovascular devices without existing testing standards, we break down complex device and pathophysiology into a justifiably simplified bench top test. Each will have well defined:

  • Operating conditions [inlet pressure, outlet pressure, internal chamber pressure (if applicable), inflow, outflow, relevant mock heart chamber pressures, cardiac output, and systolic duration
  • Test fluid properties (Chemical composition, temperature, viscosity, density, pH)
  • A priori defined acceptance criteria such as acceptable pressure drops, retrograde flow, etc.

Our test plans and reports are designed around approval bodies, thoroughly researched, and justified to ensure they are regulatory appropriate.

Contact us today to discuss your requirements.

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VICTORIA LAB accreditation scope

 

MARSEILLES LAB accreditation scope

Accredited ISO 17025:2017 – N° 1-6611
Scope available on www.cofrac.fr

 
 

DAY IN OUR LAB Option

DAY IN OUR LAB gives access to ViVitro equipment and the use of one lab tech for an entire day in Victoria, Canada. This low-cost option gives immediate access to ViVitro expertise and equipment.

Customer satisfaction surveys are an integral component of our Quality Management System (QMS) and a requirement for ISO 17025 accreditation.  We encourage clients to take this short survey managed by ViVitro’s QA department.

 

ViVitro Labs Advantages

Many companies look to academia to handle their testing needs due to the reduced cost.  With ViVitro Laboratory Services you gain the following advantages:

Time to Market
We  understand how critical your timelines are. We work to your schedule and deliver to our commitments. We design unique tests to meet specific developmental needs.

ISO 17025 Accredited by A2LA
For studies used for regulatory approval this is a must. Our trained researchers, calibrated equipment, and internal audits meet ISO 17025 standards.

Free Set-Up Consultations
All of our feasibility studies are developed via no-cost, no obligation, collaborative consultation.

Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.

 

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