STOCKHOLM, May 11, 2021 /PRNewswire/ -- IRRAS AB, a
commercial-stage medical technology company with a comprehensive
portfolio of innovative products for neurocritical care, announced
today that the CE Mark certificates for its IRRAflow system
and the company's ISO13485:2016 certification have been transferred
to a new notified body, DEKRA. After the successful completion of a
recent audit by DEKRA, these CE Mark certificates for
IRRAflow will remain valid until May 2024.
"With DEKRA, we are building a relationship with one of the
largest, most respected notified bodies in the world," said
Will Martin, President and Chief
Commercial Officer of IRRAS. "DEKRA has resources in place near our
US headquarters in Southern
California, so important regulatory work has continued
despite Covid-19. We believe that this transition can shorten our
approval timelines and allow us to consistently plan our European
product introductions moving forward."
"Consolidating our regulatory relationships with DEKRA, a global
leader in the space, as our notified body is an important step in
the long-term growth of IRRAS," said Kleanthis G. Xanthopoulos, PhD., Chief Executive
Officer of IRRAS. "Regulatory requirements have changed
dramatically in Europe, and, as
guidelines evolve, it is critical that we take needed steps to
ensure that our life-saving products remain available to patients
in Europe."
Founded more than 95 years ago, DEKRA is the leading expert
organization and largest notified body in Europe. DEKRA is one of the five largest
notified bodies globally and was also one of the first notified
bodies to be approved under Europe's new Medical Device Regulations. The
company currently employs more than 43,000 people in approximately
60 countries on six continents.
About IRRAS
IRRAS is a global medical care company focused on delivering
innovative medical solutions to improve the lives of critically ill
patients. IRRAS designs, develops, and commercializes neurocritical
care products that transform patient outcomes and decrease the
overall cost of care by addressing complications associated with
current treatment methodologies. IRRAS markets and sells its
comprehensive, innovative IRRAflow and Hummingbird ICP
Monitoring product lines to hospitals worldwide through its direct
sales organization in the United
States and select European countries as well as an
international network of distribution partners.
IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in
Munich, Germany, and San Diego, California, USA. For more
information, please visit www.irras.com.
IRRAS is listed on Nasdaq Stockholm (ticker: IRRAS).
For more information, please contact:
USA
Kleanthis G. Xanthopoulos,
Ph.D.
CEO
ir@irras.com
Europe
Sabina Berlin
CFO
+46 73 951 95 02
sabina.berlin@irras.com
The information was released for public disclosure, through
the agency of the contact person above, on May 11, 2021 at 08:30 (CET).
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SOURCE IRRAS