Bergen, Norway, October 12th, 2023: Today, Lifecare AS (LIFE), a clinical stage medical sensor company developing the next generation Continuous Glucose Monitor (CGM), can disclose that Lifecare Laboratory (Mainz, Germany) is considered ready for ISO 13485 audit.
ISO 13485 is a Quality Management System specific to medical devices and covers the entire life cycle of a device, from design and development to production, installation, and servicing.
Reference is made to Lifecare’s list of trigger events, as presented at the semi-annual report of August 20th, 2023, and later investor communication. The launch of an automated production line at Lifecare Laboratory by end of Q2 2024 is set as a major milestone, and on this basis the company aim to launch the first product in the veterinary market mid 2024.
Lifecare has received confirmation that ISO 13485 audit at Lifecare Laboratory will be carried out in the course of November 2023. Provided a successful audit, the ISO 13485 Certificate can be expected issued early in 2024. This progress is in accordance with the current list of communicated trigger events.
In April 2023, Lifecare Laboratory was ISO 9001 certified in line with the progress plan. Given a successful outcome of the upcoming audit, Lifecare Laboratory will be ISO 13485 Certified. Compliance with ISO 13485 is an important step on the route towards Lifecare’s ultimate goal; product CE mark necessary to enter the market with a medical device for humans.
Photo: CEO Joacim Holter
– Lifecare’s QMS team in Bergen and Mainz has worked structured over time to prepare us for this audit. It is vital for the integrity for the production of Sencell Continuous Glucose Monitor, and later commercialization of the product, that our Quality Management System are certified. We depend on the trust from the market and patient groups, that our processes meet international quality standards. It is therefore very motivating to be ready for the important round of certification in line with the timetable that we have communicated, says CEO Joacim Holter.
For further information, please contact:
Joacim Holter, CEO, Lifecare AS, firstname.lastname@example.org, +47 40 05 90 40
Asle Wingsternes, Head of Communications & Public Affairs, email@example.com, +47 41 61 42 52
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.