Information about Brighter’s ISO 13485 certification.
On 20 June 2019, Brighter was certified under ISO 13485:2016 – the internationally recognized standard that defines the regulatory requirements for medical devices and related services in Europe. The standard is well established and accepted worldwide.
ISO 13485 is based on ISO 9001, the more general certification for quality management systems. ISO 13485 includes additional requirements specific to the medical technology sector, and includes all stages of manufacturing – from design to production and maintenance – as well as related services.
The certification means that the need for third-party audits and audits is decreases, that the company meets the frequent customer requirement for certificates and that Brighter's overall level of trust and credibility in the commercialization activities increases. It also means that products in the lower security classes can be CE marked by Brighter itself.
Brighter's CEO Henrik Norström commented the certification:
“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.”
Actiste, the company's flagship solution, is Brighter's first product. While Actiste targets diabetes, Brighter's broad IP platform can be applied to a number of additional therapeutic areas where medicine is injected. Brighter works actively with product and patent development, and intends to launch additional products in the future. This certification reduces the need for external auditing and enables more efficient development of these products.
In 2018, the US Food and Drug Administration (FDA), which is responsible for the regulation of medical devices in the United States, announced its intention to replace its current quality assurance legislation with ISO 13485.
For further information, please contact:
Henrik Norström, CEO
Phone: +46 733 40 30 45
Email: henrik.norstrom@brighter.se
About Actiste.
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, info@eminova.se, www.eminova.se.