Medical device start-up Portal Instruments said today that it won ISO 13485:2012 certification from the National Standards Authority of Ireland. The Cambridge, Mass.-based company is developing a hand-held, needle-free drug delivery device.
The device can precisely administer high viscosity biologics directly through the skin using a collimated jet that is the size of a strand of hair, Portal said. The computer-controlled tech collects injection data to be shared between the patient and their team of caregivers.
Portal’s drug delivery technology delivers a 1 milliliter dose in half of a second, according to the company, and it automatically adjusts the injection velocity up to 1,000 times for every dose.
“We are delighted to receive ISO 13485 certification from NSAI,” CEO Patrick Anquetil said in prepared remarks. “This certification provides current and future customers with confidence and trust in Portal’s Quality Management Systems and strengthens Portal’s commitment to client quality and end-user service. It is a first step in positioning the company for expansion in the medical device marketplace.”
“ISO 13485 certification shows Portal Instruments’ on-going commitment to ensuring that the medical devices designed and built comply with state-of-the-art standards, and are manufactured under closely monitored processes that ensure the consistent quality of their products,” NSAI’s VP Chris Morrell added.
In March, the company closed the 2nd tranche of its $25 million Series B round, led by 5AM Ventures. Sanofi Sunrise and other existing private investors also contributed to the round.