ViVitro Labs provides contract performance testing services on finished goods to cardiovascular device manufacturers using recognized or unrecognized methods and equipment for regulatory and non-regulatory testing purposes.  The ViVitro team provides extensive cardiovascular testing know-how and experience to your project. An active member of several ISO and ASTM working groups, ViVitro Labs is always on the forefront of innovation and regulation.  ViVitro Labs offers cardiovascular device testing services as either ISO 17025:2017 accredited by A2LA (Victoria and Marseille) or non accredited to help device manufacturers meet the highest standards in the industry in support of regulatory submissions.

Vivitro Labs has developed a rigorous process for Test Method Validation which is applied to both accredited and non accredited test methods.   Test method validation refers to a systematic and documented process of confirming that a specific test method is suitable for its intended purpose and meets certain established criteria for accuracy, precision, reliability, and repeatability.   To prove validation, objective evidence that the method meets the requirements for its intended use must be provided. The validation shall be as extensive as is necessary to meet the needs of the given application.

“We are even more delighted to see that we are choosing the right partners to work with: your frankness and openness with us are outstanding, and they are helping to strengthen the long business relationship between us.”

Medical Technology Client

Check out our most current ISO 17025 Accredited and Validated test methods

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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:

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Victoria and Marseille labs accredited by A2LA.

Test Method Validation
The FDA and Notified Bodies around the world are requiring evidence of Test Method Validation. ViVitro Labs has invested significant resources to validate the most common test methods that are not ISO 17025 accredited. We continue to work closely with device manufacturers and share the burden with our clients to validate other specific test methods that are less in demand.

Timeliness
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.

Free Initial Consultations
All of our studies are scoped 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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