Brain+ Completes The Implementation Of An ISO 13485 Quality Management System For Medical Devices

On the 14h of December 2022, Brain+ A/S (“Brain+” or the ”Company”) announced that the Company has successfully completed the implementation of an ISO 13485-compliant Quality Management System (QMS). The latest WHO report also points to Cognitive Stimulation Therapy (CST) and digital solutions as means to help solve the global dementia burden, which gives Brain+ dementia products further attestation.

ISO 13485 specifies requirements for a quality management system (QMS) where an organization needs to showcase the ability to provide medical devices and related services that ensure, on a consistent basis, patient safety and process quality along the product life cycle, as well as meet applicable regulatory requirements. The completed implementation of the ISO 13485 QMS provides Brain+ with an important quality stamp. However, ISO 13485 is effectively required for getting a medical device to market under the MDR framework and, as such, this implementation by Brain+ takes the company one step further into CE-marking and the ongoing commercialization. ISO 13485 is also important when attracting payers, including Germany´s DiGA and DiPA reimbursement schemes, as they are relying on this certification as proof of quality. The goal for Brain+ is to get their upcoming product launches of CST-Home Care and CST-Stand Alone reimbursement, which ISO 13485 certification enables. The QMS-certification means that Brain+ has incorporated a quality best practice that ensures that its software products meet all the general safety and performance requirements (GSPR), which not only assure regulatory compliance and enables product reimbursement at scale, but also attract large pharma partnership, which paves the way for a continued successful launch going forward.

World Health Organization (WHO) recently published a report – A Blueprint For Dementia Research – in which the specialized agency in international public health addressed dementia as one of the greatest health challenges of our generation. In the report, WHO points out that insufficient numbers and an under-skilled workforce are barriers to the provision of good-quality dementia care today on a global basis. At the same time, WHO validates that rehabilitative interventions such as Cognitive Stimulation Therapy (CST), among others, can improve cognition, function, stability, and/or the quality of life of people with dementia. Furthermore, WHO also mentions that some psychological interventions are effective tools when delivered digitally, for instance, through websites, apps, and telehealth. This report is the second of its kind* that has been released in 2022 that endorses CST which, in turn, gives not only increased validation for Brain+ digital dementia offerings, but also wider recognition for companies like Brain+, which paves the way for faster adoption of these types of DTx-products and improves the long-term outlook for Brain+ ongoing commercialization.

Read our latest equity report of Brain+ here.

*In October 7, 2022, the World Alzheimer Report was published, which highlighted CST as cost-effective evidence-based therapy for people with mild-to-moderate dementia that should be researched and implemented globally.