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ListaEuronext Growth Oslo
Lifecare är ett norskt bolag verksamma inom medicinteknik. Idag är bolaget specialiserade inom forskning och utveckling av diabetes. Produkterna är patenterade och används som glukosgivare. Mikrosensorerna injiceras under huden på patientens handled, och fungerar vidare som en realtidsuppdatering av glukosnivån i patienten. Utöver bidrar tekniken med larmsensor samt tillgång till historisk data över patientens glukosnivå. Bolaget etablerades under 2006 och har sitt huvudkontor i Bergen, Norge.
2023-03-23 09:22:06
Lifecare is pleased to announce that its wholly owned subsidiary Lifecare
Laboratory GmbH in Mainz, Germany, has been successfully audited as part of the
upcoming ISO certification. "It is reassuring that our operational organization
has passed this audit without any major findings. This is a good fundament for
our continued work on regulatory processes." says CEO Joacim Holter.

Lifecare's main focus is to achieve regulatory approval to bring the smallest
glucose sensor in the world to the market. Starting 2021, the Lifecare Group has
been significantly staffed up, and it has been a priority to ensure a high
degree of quality, throughout the growing corporate organization. Our ultimate
goal, the CE-mark for our osmotic-pressure based sensor technology, depends on
ISO certification of the Lifecare organization. Lifecare has prioritized to
implement the general ISO 9001 in the first step as the core building block in
our regulatory system. This ISO forms the basis for the Medical Device-specific
ISO 13485, which in turn is the fundament for the regulatory sensor approval.

"In previous communications, we have indicated the importance of this milestone,
for the Lifecare organization and in particular for the planned sensor
manufacturing infrastructure and premises. It has been an extensive process, and
we are grateful that the organization has accomplished this task as planned in
Q1", emphasizes Holter.

The importance of ISO 9001
ISO certification ensures consistent quality and induces the effort for constant
improvement in providing goods and/or services and improve customer
satisfaction. Senior QMS Manager Barbora Tencer conveys why Lifecare has decided
to be ISO certified at this development stage. "ISO 9001 is the world's most
recognized Quality Management System standard. It is a process-oriented approach
and forms the basis for our strategic development towards ISO 134585 and later
CE-mark approval, in line with current European regulatory requirements", she

According to Tencer, the organization has been working intensively towards the
audit for more than nine months. The company provided the necessary resources,
went through essential procedures (such as initial gap analysis, review and
adjustment of existing standard operating procedures (SOP), preparation of new
SOPs, internal audits, management reviews etc.) prior to the audit, which was
conducted by the notified body Deutsche Gesellschaft zur Zertifizierung von
Qualitätsmanagementsystemen (DQS) in February and March, 2023. The auditor from
of DQS was satisfied by the maturity of the implemented system and announced in
the absence of any major findings that issuance of certificate will be

"It is satisfying to have come this far in this process and obtain
recommendation for certification. ISO 9001 is not only of symbolic value to us,
but a significant milestone on our path to establish an accepted and approved
manufacturing unit for our upcoming sensor production." says CEO Holter.
"Lifecare's next quality management goal is to upgrade the Quality Management
System in accordance with ISO 13485 in parallel to setting-up our sensor
manufacturing unit."


For more information: CEO Joacim Holter, joacim.holter@lifecare.no , +47 400 59

This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to Section 5-12 the Norwegian Securities Trading Act. This stock exchange
announcement was published by Joacim Holter, CEO at Lifecare AS, on 23 March
2023 at 09:22 CET