Bergen, Norway, October 12th, 2023: Today, Lifecare AS (LIFE), a clinical stagemedical sensor company developing the next generation Continuous Glucose Monitor(CGM), can disclose that Lifecare Laboratory (Mainz, Germany) is consideredready for ISO 13485 audit.
ISO 13485 is a Quality Management System specific to medical devices and coversthe 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 thesemi-annual report of August 20th, 2023, and later investor communication. Thelaunch of an automated production line at Lifecare Laboratory by end of Q2 2024is set as a major milestone, and on this basis the company aim to launch thefirst product in the veterinary market mid 2024.
Lifecare has received confirmation that ISO 13485 audit at Lifecare Laboratorywill 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 isin accordance with the current list of communicated trigger events.
In April 2023, Lifecare Laboratory was ISO 9001 certified in line with theprogress plan. Given a successful outcome of the upcoming audit, LifecareLaboratory will be ISO 13485 Certified. Compliance with ISO 13485 is animportant step on the route towards Lifecare's ultimate goal