Lifecare is pleased to announce that its wholly owned subsidiary LifecareLaboratory GmbH in Mainz, Germany, has been successfully audited as part of theupcoming ISO certification. "It is reassuring that our operational organizationhas passed this audit without any major findings. This is a good fundament forour continued work on regulatory processes." says CEO Joacim Holter.
Lifecare's main focus is to achieve regulatory approval to bring the smallestglucose sensor in the world to the market. Starting 2021, the Lifecare Group hasbeen significantly staffed up, and it has been a priority to ensure a highdegree of quality, throughout the growing corporate organization. Our ultimategoal, the CE-mark for our osmotic-pressure based sensor technology, depends onISO certification of the Lifecare organization. Lifecare has prioritized toimplement the general ISO 9001 in the first step as the core building block inour regulatory system. This ISO forms the basis for the Medical Device-specificISO 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 sensormanufacturing infrastructure and premises. It has been an extensive process, andwe are grateful that the organization has accomplished this task as planned inQ1", emphasizes Holter.
The importance of ISO 9001ISO certification ensures consistent quality and induces the effort for constantimprovement in providing goods and/or services and improve customersatisfaction. Senior QMS Manager Barbora Tencer conveys why Lifecare has decidedto be ISO certified at this development stage. "ISO 9001 is the world's mostrecognized Quality Management System standard. It is a process-oriented approachand forms the basis for our strategic development towards ISO 134585 and laterCE-mark approval, in line with current European regulatory requirements", shesays.
According to Tencer, the organization has been working intensively towards theaudit for more than nine months. The company provided the necessary resources,went through essential procedures (such as initial gap analysis, review andadjustment of existing standard operating procedures (SOP), preparation of newSOPs, internal audits, management reviews etc.) prior to the audit, which wasconducted by the notified body Deutsche Gesellschaft zur Zertifizierung vonQualitätsmanagementsystemen (DQS) in February and March, 2023. The auditor fromof DQS was satisfied by the maturity of the implemented system and announced inthe absence of any major findings that issuance of certificate will berecommended.
"It is satisfying to have come this far in this process and obtainrecommendation for certification. ISO 9001 is not only of symbolic value to us,but a significant milestone on our path to establish an accepted and approvedmanufacturing unit for our upcoming sensor production." says CEO Holter."Lifecare's next quality management goal is to upgrade the Quality ManagementSystem in accordance with ISO 13485 in parallel to setting-up our sensormanufacturing unit."
For more information: CEO Joacim Holter, firstname.lastname@example.org , +47 400 59040
This information is considered to be inside information pursuant to the EUMarket Abuse Regulation and is subject to the disclosure requirements pursuantto Section 5-12 the Norwegian Securities Trading Act. This stock exchangeannouncement was published by Joacim Holter, CEO at Lifecare AS, on 23 March2023 at 09:22 CET