Medical Devices Testing
+972-54-22-99-573
Ylabs services are tailored to meet customers needs and standards requirements. We provide the exact engineering support to efficiently address the requirements of the product development process stages.
Ylabs quality system is certified to ISO 13485:2016
SERVICES
CONSULTING SERVICES
Ylabs consulting services include all aspects of medical devices design verification.
Contact us to find the solutions you need.
ABOUT
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.
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.
FATIGUE TESTING
Our very own FT-7206 is designed to perform fatigue studies for materials, components and devices.
With the capability of simultaneously testing up to 6 components at up to 120 Hz, with high statistical confidence level.
ADDITIONAL TESTS
We offer a wide variety of elementary material and specimen testing services:
-
Corrosion test
-
AF temperature
-
Radial force testing
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.
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.
Ylabs is named after Yiftach Rapoport (Mor and Danny’s son). Yiftach was killed in an accident while passing through a crosswalk on his way to school, on the morning of September 16, 2014.
We will always love and remember him.
CONTACT US
Kherut St, Yavne, Israel
+972-54-22-99-573