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Training & Testing Services

We customize testing for each of our client’s medical devices, instead of performing the “whole nine yards” of testing as recommended by other labs.

In addition, we prepare the binder for each testing for submission to regulatory agencies, support preparation of submission documents, and provide support for post-test questions if any arises from the regulatory agencies. We communicate with the regulatory agencies as a company representative to discuss testing needs and resolve any questions they may have.

In all of the projects we have undertaken, we were able to save valuable time and cost for our clients. At the same time, our work was well accepted and approvals were granted by the regulatory agencies.

Following are some of the area where we offer our testing services:

testing services

  • Biocompatibility and Toxicology
  • Microbiology
  • Bio burden
  • Sterility
  • Sterilization validation
  • Viral Inactivation
  • TSE/BSE inactivation
  • Chemical Analysis
  • Chemical residual testing

training services

We have the required industry experience and focused knowledge to deliver the results.

  • Tissue cleaning, cutting, cross linking, etc.
  • Chemical lab setup and solution preparation.
  • Tissue sewing to stent.
  • Train personnel in the various skills needed to manufacture the valve.