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.
Senior QMS Manager Barbora Tencer and CEO Joacim Holter
“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 says.
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 representative 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 recommended.
“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.”
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For more information: CEO Joacim Holter, joacim.holter@lifecare.attme.dev,
+47 400 59 040