Ylabs quality system is certified to ISO 13485:2016 

SERVICES

HYDRODYNAMIC TESTING

According to the ISO 5840 standard, heart valve substitutes shall be tested under steady back flow and pulsatile flow conditions to determine their fluid mechanical performance.

Ylabs provides Hydrodynamic testing services using the BDC HDT-500 pulse duplicator for the pulsatile flow and a dedicated setup for the steady back flow test.

DURABILITY TESTING

The heart valve durability test (also referred to as Accelerated Wear Testing - AWT) is performed to demonstrate that the heart valve will remain functional over a resonable lifetime (at least 200 million in vitro cycles according to the ISO 5840 standard)

Ylabs is equipped with BDC VDT-3600i  testers to carry out durability testing according to all the requirements depicted in the standard.

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TENSILE TESTING

Tensile testing is performed for several purposes. Most common purpose is to verify the bonds of catheters and delivery systems.

Ylabs offers tensile testing services that fit to customer needs and requirements.

CONSULTING SERVICES

Ylabs consulting services include all aspects of medical devices design verification.

Contact us to find the solutions you need.

Danny Rapoport founded Ylabs with the vision to provide testing and consulting services for start-up companies in the medical device industry.

Danny has extensive experience in  medical devices design verification. In the last 15 years, Danny has been involved in product development and  testing of more than 10 medical device's companies (both in the orthopedic and cardio-vascular fields).

Danny holds an MSc  in Mechanical Engineering from the Tel-Aviv University.

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As the medical device's companies continue to rocket –  fast an reliable testing are in great need  in the industry. Ylabs is here to deliver.