Ikonisys Successfully Completed Its ISO Certification Reaffirming Its Ability to Continuously Meet Quality International Standard Requirements
16 Oktober 2023 - 6:00PM
Business Wire
Regulatory News:
Ikonisys SA (ISIN Code: FR00140048X2 / Ticker: ALIKO)
(Paris:ALIKO), a company specializing in the early and accurate
detection of cancer with a unique fully-automated solution for
medical diagnostic labs, today announces the successful completion
of its triennial Registration Renewal ISO Audit by its US
subsidiary.
Ikonisys, Inc. has completed a three-day ISO recertification
audit leading to the revalidation of the ISO 13485. This standard
indicates that the company is following a procedure recognised by
an independent body that audits it regularly. Certification also
simplifies the CE marking of products marketed by a company.
Concretely this obtention validates the conformity of the following
strategic items:
- compliance with regulatory requirements,
- control of special processes,
- risk analysis throughout product development,
- organisation of material vigilance,
- traceability of the configuration of each medical device
delivered.
Dr. Michael Kilpatrick, Chief Scientific Officer of
Ikonisys: “We are very pleased to announce this highly
successful audit which resulted in zero non-conformances. Such an
impressive result ensures that the company meets or exceeds all of
the rigorous quality elements required by this international
standard. Completing the audit so successfully indicates the
ability of Ikonisys to continue to meet FDA requirements in the
USA. In addition, it allows Ikonisys to continue to provide CE
marking for its products, as we work toward full conformance with
the IVDR, the new EU regulation on medical devices”.
About Ikonisys
Ikonisys SA is a cell-based diagnostics company based in Paris
(France), New Haven (Connecticut, USA) and Milan (Italy)
specialized in the early and accurate detection of cancer. The
company develops, produces and markets the proprietary
Ikoniscope20® platform, a fully-automated solution designed to
deliver accurate and reliable detection and analysis of rare and
very rare cells. Ikonisys has received FDA clearance for several
automated diagnostic applications, which are also marketed in
Europe under CE certification. Through its breakthrough
fluorescence microscopy platform, the company continues to develop
a stream of new tests, including liquid biopsy tests based on
Circulating Tumor Cells (CTC).
For further information, please go to www.Ikonisys.com
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Ikonisys Alessandro Mauri CFO investors@ikonisys.com
NewCap Aurélie Manavarere/Louis-Victor Delouvrier
Investor Relations Ikonisys@newcap.eu Tel. : +33 (0)1 44 71 94
94
NewCap Nicolas Merigeau Media Relations
Ikonisys@newcap.eu Tel. : +33 (0)1 44 71 94 98
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