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ITL is the first in ISRAEL, to become an Accredited Testing Laboratory by the US FDA – TL 23
The FDA ASCA program is voluntary and targets medical device manufacturers undergoing 510(k) premarket notification and other regulatory reviews required in order to sell their devices on the US market.
Increased confidence in testing results obtained from FDA ASCA accredited laboratories
Greater Predictability for manufacturers in FDA medical device clearance processes.
More consistent and efficient FDA assessments of medical device safety and performance testing to reduce risks to public health.
ITL has gained momentum in the global arena. The company inaugurated a European branch in Cyprus and accomplished an impressive achievement in the US market, with the establishment of a branch in Maryland and the acknowledgement as an independent laboratory for electrical equipment for hazardous locations by the Department of Homeland Security (DHS) - US Coast Guard.
This impressive international status won by the company as an exclusive Israeli representative in this field provides a global solution to the certification of hazardous location products, with the mutual acknowledgement of 40 states.