Helping Brain Stimulation AB
lead safe innovation
through regulatory change
Industry
Healthcare & Life Sciences
Service Line
Regulatory Consulting
Context
Brain Stimulation AB, founded in 2011 in Umeå, Sweden, has been dedicated to designing and developing medical technology products inspired by research from Umeå University. Collaborating closely with leading scientists and clinicians, the company has created patient-centric solutions that support cognitive functions assessment and offer effective training tools to support acquired brain injury recovery, such as stroke and neuro-rehabilitation.
Brain Stimulation developed the RehAtt® method which is a theoretically designed method that has promising behavioral effects on the function of attention, in tests and activities of daily living.
- RehAtt® DiSTRO (Cognitive Assessment) is a digital platform for cognitive assessments designed to help diagnose and assess the health status of patients with acquired brain injuries, such as stroke. It aligns with clinical guidelines and supports safer discharges, personalized rehabilitation and better recovery outcomes.
- RehAtt® XR (Rehabilitation) is a digital system for cognitive and motor rehabilitation tailored to patients with acquired brain injuries. It enables healthcare professionals to create personalized plans based on the patient's specific needs and progress. XR features interactive 3D games integrated into the environment as holograms, combining multisensory stimulation with original designs to enhance engagement, boost participation and accelerate recovery.
The combined use of the RehAtt® DiSTRO and the RehAtt® XR provides further benefits by providing a set of highly valuable information from cognitive screening, impairments of visual attention and monitoring data of improvements.
As a manufacturer of medical devices, Brain Stimulation AB was fully aware of the complexity of the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) and the associated timeframe boundaries. Star's reputation for excellence in regulatory and quality management has attracted Brain Stimulation AB, which has engaged our services to enhance its regulatory readiness and product innovation.
Impact
With the support of Star, Brain Stimulation was able to achieve successful outcomes:
- The initial MDR audit was successfully completed, thereby guaranteeing continued compliance and the capacity to pursue sales and innovation in the European Union market
- RehAtt® DiSTRO is ready to be placed on the US market as a class II medical device after FDA listing procedure
- A scalable quality management system (QMS) was established and implemented in order to adapt to regulatory changes and maintain a competitive edge
These milestones position Brain Stimulation AB to expand globally while sustaining innovation in the field of neurology for patients with acquired brain injuries, such as stroke, and the subsequent rehabilitation process.
Testimonial
“Star's proficiency in quality and regulatory compliance has been pivotal in enabling us to successfully navigate complex challenges and bring our innovations to market. Agata's dedication and commitment to precision have instilled confidence in our ability to expand globally while maintaining compliance with evolving regulations.”
Anders Markstedt, CTO, Brain Stimulation
Journey
In the healthcare sector, innovation and compliance are essential to success. Star's approach enabled Brain Stimulation to achieve critical regulatory milestones while embedding scalable, continuous improvement practices into its systems.
“Our objective was to provide guidance on immediate regulatory requirements and to equip Brain Stimulation AB with systems that facilitate continuous innovation. By integrating a scalable quality management system, we can continuously assist them in meeting the highest standards while maintaining flexibility in response to future regulatory changes.”
Agata Piskor, Quality and Regulatory Affairs Manager, Star
Establishing Quality Management System
Star collaborated with Brain Stimulation AB to define and implement a bespoke quality management system (QMS) aligned with their specific requirements. This included the introduction of tailored quality and risk management, product and software lifecycle oversight, and a continuous improvement process.
By employing Star's ins2out compliance management system, workflows were streamlined in order to meet MDR compliance in Europe and FDA requirements in the USA.
Within six months, the QMS was fully operational, supporting both RehAtt® Distro and RehAtt® XR. It continues to play a critical role in Brain Stimulation's product and innovation lifecycle management.
Controlled product development and records
It is crucial to develop software medical devices in a controlled environment under a solid quality management system to ensure their safety and efficacy. Star team supported the product team in adoption of all the QMS processes and creation of all the relevant technical documentation and records throughout the product life cycle to streamline the conformity assessment process in each market of interest.
Continuous improvement
To ensure long-term regulatory readiness, Star is working closely with the Brain Stimulation team on compliance workflows and ongoing regulatory and quality updates. The regular documentation reviews and process iterations that Star has established empower the team to adapt to changes in a timely manner, in accordance with the requirements set out in applicable standards and regulations.
Brain Stimulation's innovative approach has the potential to transform the lives of thousands of post-stroke patients worldwide. Star is proud to have contributed to this ground-breaking work and looks forward to supporting their continued success. The EU and US markets are just the beginning of this journey.
