Brighter has received ISO 13485 certification.
Brighter's quality management system has now been certified under ISO 13485. The same Notified Body that issues the certificate is working with the Actiste CE marking (EC-Certification). That process is in its final phase.
“This is very good news that means that the Notified Body CE marking Actiste have great confidence in our quality assurance processes. This is a necessity for obtaining the Actiste CE mark and certification of future products,” says Henrik Norström, Brighter’s CEO.
Further information about the company's ISO 13485 certification will be communicated after the Midsummer weekend.
On June 13, the company released an update on both the ISO 13485 certification process and the CE marking process.
For further information, please contact:
Henrik Norström, CEO
Phone: +46 733 40 30 45
Brighter's solution Actiste® handles most of the self-monitoring and treatment of insulin-treated diabetes in a single easy-to-use device. Measurement of glucose levels, insulin injections, automatic logging, and timing of all activities are performed from a single unit. Actiste is connected via an autonomous and secure mobile connection, and information can be automatically shared with selected recipients through The Benefit Loop®, Brighter's open cloud-based service where data is collected, processed and analyzed with patient consent.
Validated user-generated data, such as glucose levels or insulin doses, can be automatically transferred electronically to many different constituents. The patient selects when and how data is shared and who will have access to it. Through The Benefit Loop, different services can motivate patients with chronic illnesses to change their behavior, which can save lives, reduce relatives' concerns, and release enormous healthcare resources. https://actiste.com/
About Brighter AB (publ).
Brighter is a Swedish-based company that, from a unique IP portfolio, creates smart solutions for one of healthcare’s biggest challenges: changing patient behavior. Chronic diseases such as diabetes are rapidly increasing, and account for an increasing share of healthcare costs globally. Brighter's Business Model and Multi-Sided Market Platform - The Benefit Loop® - is based on the fact that many special interests create value for each other. By increasing access to valid health data, Brighter creates value for all stakeholders in the care chain: patients and their close associates, healthcare providers, research institutes, the pharmaceutical industry, and society as a whole. https://brighter.se/
The Company's shares are listed on NASDAQOMX First North/BRIG. Brighter’s Certified Adviser on Nasdaq OMX First North is Eminova Fondkommission AB, +46 (0)8 – 684 211 00, email@example.com, www.eminova.se.
This information is information that Brighter AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 16:07 CET on June 19, 2019.