Brain+ completes the implementation of an ISO 13485

Quality Management System for Medical Devices
  • Having a standardized Quality Management System in place is a key requirement for the development and commercialization of compliant digital therapeutics
  • Meeting this milestone supports the company’s objective to attract large pharma partnerships and ensure product reimbursement at scale

Brain+ has successfully completed the implementation of an ISO 13485-compliant Quality Management System (QMS). Such a system helps to set standards to ensure stringent processes throughout every step of a medical device product’s life cycle and thus to maintain a high product quality. This milestone is therefore an important step on Brain+’ path toward becoming a mature supplier of software-based medical devices for Alzheimer’s disease and other forms of dementia.

Working within the framework of a standardized QMS is also a key quality stamp for both large healthcare customers and industrial partners such as pharmaceutical companies and for government institutions and reimbursement systems, many of whom require compliance with the ISO 13485 QMS from their medical device suppliers to ensure that they receive the highest quality products. An ISO 13485 system ensures that the medical device products and related services such partners receive, meet all applicable regulatory requirements and are safe and effective at all times throughout their lifecycle. Many payer systems, including Germany’s DiGA and DiPA reimbursement schemes, rely on ISO 13485 compliance as a proof of quality, enabling reimbursement in Germany.

CEO & Co-founder, Kim Baden-Kristensen

The completion of our QMS is a testament to our patient and caregiver commitment and our dedication to developing both safe and highly effective digital therapeutics to improve the lives of people living with Alzheimer’s disease and other types of dementia.
ISO 13485:2016 standard for medical devices

The 13485 standard is a quality management system standard specific to medical devices, and it includes requirements for mapping and meeting all needs of customers, regulators, and all other stakeholders, as well as for risk management activities throughout the lifecycle of our products. By meeting the requirements of this standard, organizations demonstrate that they have the processes in place to comply with applicable regulations at all times and can thus have their products approved for reimbursement by buyers of medical devices.

Ensuring the highest standards of safety, performance, and reliability

With the QMS in place, Brain+ is ready to develop medical device software products that meet the highest standards of safety, performance, and reliability at all times. The QMS consists of procedures for how Brain+ plans, performs, measures, and evaluates work being done, enabling the company to ensure that the software products meet all safety and performance requirements, and enabling the company to continuously improve. 

We look forward to continuing to develop and commercialize products that meet the highest standards of safety, performance, and reliability.

Invitation to Brain+ year-end investor webinar   

Brain+ will host an investor webinar on December 22, 2022, from 16:30 to 17:00 CET to update on the company’s commercial activities and plans and give a status on product development, pipeline projects, and partnering activities. 

Sign up for the investor webinar here: