949 315 7200

Our Partial Client List

We provide Biocompatibility Testing and Solutions to full range of medical devices for FDA 510K and CE marking (ISO 10993)

testing medical devices
testing medical devices
testing medical devices
testing medical devices
testing medical devices
testing medical devices
testing medical devices
testing medical devices
testing medical devices
testing medical devices
testing medical devices
testing medical devices
testing medical devices
testing medical devices
testing medical devices
testing medical devices

Get in touch and know more about us

You don’t need just a lab to do your biocompatibility studies you need a solutions provider who can guide and advice the right solutions which is suitable to your device. We have provided our services to startups to global medical device companies. What makes special is our ability to put ourselves in our clients shoes and understand their needs whether it is the device, tests, prices, regulatory approvals, etc. It seems to us that this approach is working as many of our clients are repeat customers. Medical device biocompatibility studies serve an important purpose, so we wanted to be more responsive, precise, and relevant by focusing only on biocompatibility testing.

Find out what Biocompatibility (FDA 510K and ISO 10993) tests your device needs?

Our number one tenet to found this company is to de-mystify the whole medical device biocompatibility testing for our clients. Also at the same time we wanted to be upfront and transparent with our clients. So please go ahead and find out what tests your device needs for yourself.

biocompatibility testing
Our Promise

Our promise is about one thing, which is – biocompatibility and nothing else. This basic ideology makes us a specialized, impeccable and efficient service provider in biocompatibility solutions. It enhances our mind set in precision thinking and increases our reliability of testing and solutions we provide.

Here is our 1, 2, 3 promise:

  • We’ll match or beat competitor prices for all biocompatibility tests
  • We’ll always try to save your testing costs by writing justification, white paper and rationales
  • We’ll always repeat the tests at no charge, if our test results are not accepted by the regulatory agencies

("TRY GETTING THIS FROM OTHER LABS...")

Client Testimonials

The team at Biocomptesting is fast, knowledgeable, and efficient at their job. We could tell they really cared for our success when they took our device and custom tailored the necessary biocompatibility tests needed for FDA 510K submission. Thanks to their expertise, we were able to introduce our device to the market far ahead of our original schedule!

Kobi Iki
VP of R&D
Baronova, Inc.

Biocomptesting provided and conducted the biocompatibility tests needed for our medical device and we couldn’t be happier! They took the project on as their own addressing our needs and concerns every step of the way. We are very pleased with their work and our device will soon be on the market thanks to their efforts.

Lex Schultheis, M.D., Ph.D.
Research Professor, Robert E. Fischell Dept. of Bioengineering
and Director, Regulatory Science
University of Maryland

It was an absolute pleasure working with Biocomptesting. They were able to deliver the testing results 3 weeks faster than originally quoted. As soon as the tests were completed, we were able to submit for FDA 510K with no worries.  Their expertise was essential in making sure our product succeeded.

Amir Ali
Chief Development Officer
Biotricity

We could tell the team at Biocomptesting are experts in their field after working with them on our medical device. They not only specially designed the biocompatibility tests needed, but produced the test reports ready for immediate FDA submission. Biocomptesting truly gets the job done!

Dennis L. Cook
President  & CEO
D R Burton Healthcare LLC

Biocomptesting provided us with the industry experts and best-in-class facilities needed for the  biocompatibility tests required for our product. They definitely went above and beyond to meet our expectations in providing the solutions we needed for our medical device.

Chris Cioffi ,
Chief Devleopment Officer
Owlet Baby Care

We’ve counted on Biocomptesting to perform the required biocompatibility tests for several of our devices now. They’ve always been reliable, providing essential guidance on the dynamic landscape of standards in the medical industry. Thanks to Biocomptesting, we’ve been able to successfully bring our products to market time and time again.

Dan Rhodes
VP-Engineering
Soberlink