Bergen, Norway, January 9th, 2024: 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) has
received the official documentation for ISO 13485 certification.
Reference is made to Lifecare's stock exchange notification 27th of November
2022 when the ISO 13495 audit was conducted, and finalized, at Lifecare
Laboratory. This progress is in accordance with the current list of
communicated trigger events.
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. Lifecare's ISO 13485 certification
covers "Development services for manufacturers of medical devices such as CGM
devices".
Lifecare's ultimate goal to enter the human market is product CE marking.
Lifecare has now received ISO 9001 and ISO 13485 certification and thus signed
off on two essential steps on the way to product CE mark.
- This was expected, but still incredibly gratifying to receive the
confirmation that we are ISO 13485 certified. This is of course a very
important step for the company and the organization. I can repeat that I am
deeply impressed by how our QMS team in Bergen and Mainz have driven this
process forward and finally received the final documentation of their
dedication and high standards when it comes to quality management. This
confirms a solid fundament for our continued work with regulatory processes,
says CEO Joacim Holter at Lifecare.
- Safety, compliance and top-class quality are our unwavering guidelines in
our market for medical devices. One thing is that there are demands from the
authorities, but ISO certification also means something for the professional
integrity of the employees, but also for the credibility of the company, says
Senior QMS Manager Barbora Tencer.
According to the International Organization for Standardization (ISO)
regulatory requirements are increasingly stringent throughout every step of a
product's life cycle, including service and delivery. Increasingly,
organizations in the industry are expected to demonstrate their quality
management processes and ensure best practice in everything they do. This
internationally agreed standard sets out the requirements for a quality
management system specific to the medical devices industry.
In November CEO Joacim Holter commented on the successful audit. - It is vital
for the integrity of 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 successfully complete the ISO 13485 audit in accordance with the
planned and communicated timeline. This is solid confirmation that Lifecares
operations are compliant with the standards necessary to develop and produce
medical devices. Lifecare will continue to improve our standards and quality
systems to ensure regulatory compliance in our upcoming operations.
About us
Lifecare AS is a clinical stage medical sensor company developing technology
for sensing and monitoring of various body analytes. Lifecare's main focus is
to bring the next generation of Continuous Glucose Monitoring ("CGM") systems
to market. Lifecare enables osmotic pressure as sensing principle, combined
with the ability to manipulate Nano-granular Tunnelling Resistive sensors
("NTR") on the sensor body for read-out of pressure variations. Lifecare's
sensor technology is referred to as "Sencell" and is suitable for identifying
and monitoring the occurrence of a wide range of analytes and molecules in the
human body.
Contacts
For further information, please contact:
Joacim Holter, CEO, Lifecare AS, joacim.holter@lifecare.no, +47 40 05 90 40
Asle Wingsternes, Head of Communications & Public Affairs,
asle.wingsternes@lifecare.no, +47 41 61 42 52
This information has been submitted pursuant to the Securities Trading Act ยง
5-12 and MAR Article 19 no. 3. The information was submitted for publication
at 2024-01-09 08:00 CET.