IntegraGen Achieves ISO 13485:2016 Certification for the Design, Manufacturing and Distribution of In Vitro Diagnostic Kits
April 23 2018 - 11:45AM
Business Wire
Regulatory News:
IntegraGen (FR0010908723: ALINT - PEA-SME Eligible)
(Paris:ALINT), a company specializing in the decoding of the human
genome with a focus on producing interpretable genomic analyzes for
academic and private laboratories and developing diagnostic tools
in oncology, today announced that it has earned ISO 13485:2016
certification from Bureau Veritas. This certification indicates
that the company’s quality management systems meet the specific
standards required for the design, development, production and
marketing of in vitro diagnostic kits, and lays the foundation for
a continuous improvement process for in vitro diagnostic kits. It
also demonstrates IntegraGen's commitment to a proper industrial
approach through the adoption of international quality standards
and demonstrates the company’s ability to best meet the needs of
its academic and industrial customers.
“Achieving ISO 13485 certification is the result of over one
year of continuous efforts and indicates that IntegraGen has taken
the necessary steps to be compliant with regulatory requirements
that govern the development and manufacturing of clinical
diagnostic kits and that we are also committed to continuous
quality improvement,” stated Bernard Courtieu, IntegraGen’s
President and CEO. “It also demonstrates that our quality system
ensures the in vitro diagnostics we develop and distribute,
including our miRpredX kit which predicts the response to anti-EGFR
treatments for patients with metastatic colorectal cancer, are
manufactured in compliance with the highest standards for safety,
product performance and reliability.”
ABOUT INTEGRAGEN
IntegraGen is a company specializing in deciphering the human
genome and producing relevant and easily interpretable data for
academic and private laboratories. IntegraGen’s oncology efforts
provide researchers and clinicians with sophisticated tools for
analysis and therapeutic individualization of treatment approaches
allowing them to tailor therapy to the genetic profiles of
patients. As of December 31, 2017, IntegraGen had 38 employees and
had generated revenue of €6.2 million in 2017. Based in Evry
Genopole, IntegraGen also has an U.S. office in Cambridge,
Massachusetts. IntegraGen is listed on Euronext Growth (ISIN:
FR0010908723 - Ticker: ALINT - PEA-SME).
For more information, visit www.integragen.com
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180423005986/en/
IntegraGenBernard COURTIEUPresident and CEOorLaurence
RIOT LAMOTTE, Tel.: +33 (0)1 60 91 09 00Chief Financial
Officercontact@integragen.comorNewCapInvestor and Media
RelationsLouis-Victor DELOUVRIER, Tel.: +33 (0)1 44 71 98
53integragen@newcap.eu
Integragen (EU:ALINT)
Historical Stock Chart
From Jun 2024 to Jul 2024
Integragen (EU:ALINT)
Historical Stock Chart
From Jul 2023 to Jul 2024