Our employees embody our expertise. Fostering a positive environment allows us to minimize attrition, ensuring the preservation of invaluable knowledge. This positivity extends to clients, turning business relationships into enduring alliances. As our team and clients explore new ventures, we embrace new opportunities.
Brighthills is an established provider of regulated software services for healthcare and medical technology companies. Our team manages the entire medical device software lifecycle including planning, analysis, development, testing, support, documentation, and ensuring compliance with regulatory requirements. We create, optimize, and implement effective and transparent processes to ensure medical solutions are approved and reach the market faster.
Support
We pair software development projects with QA-specific activities. These include ensuring compliance with applicable procedures, advising on process optimization, and reviewing ongoing production records.
Preparation
We get existing deliverable packages ready for streamlined evaluation by identifying gaps and suggesting ways documentation can be improved.
Guidance
We provide expertise in FDA and MDR-compliant software development methods to MedTech start-ups and other partners with limited resources to build their own quality and regulatory teams.
Maintenance
We prepare previously certified products’ supporting documentation for resubmission, which may be necessary due to significant product changes or to ensure compliance with updated regulations.
The app lets users describe symptoms, share images, and consult dentists virtually. Dentists, via the web platform, assess and provide instructions, filtering patients by location. Dentalive doesn't stop at immediate care; it pioneers future algorithms. Our design includes a teaching module, allowing dentists to mark issues on images. A specialized algorithm aims to recognize patterns, offering diagnostic recommendations. This marks a significant stride in efficient dental healthcare, combining immediate solutions with a vision for advanced diagnostics.
The Smart Asthma application, paired with a specially designed hardware solution, allows patients to conveniently monitor peak flow. This innovative approach seeks to offer alternatives for asthma treatment, providing an efficient tool for both patients and physicians. The development journey involved a meticulous pilot effort, optimizing procedures and ensuring accuracy through rigorous testing. With over 15,000 hours invested, the culmination was the achievement of the CE mark in 2018, marking a significant milestone in our commitment to revolutionizing asthma care.
Key benefits include a device-independent, cost-efficient platform with optimized processes, low licensing fees, and robust analytics tools for enhanced efficiency. The system integrates a Laboratory Information System (LIS) for comprehensive laboratory management, including analytical tests, patient administration, and invoicing. Developed by blood bankers, it includes modules for donor management, pre-donation health history assessment, donor recruitment, and staff scheduling. The solution meets industry standards, prioritizing blood component safety and audit tracking, and addresses the diverse needs of blood banks.
With over 20 years of experience in the U.S. market, our team possesses a deep understanding of FDA and other regulatory authorities’ requirements. This expertise extends to regulated software development and SaMD, Quality Assurance, and Regulatory Affairs domains.
Our low attrition levels, coupled with our significant domain knowledge, have allowed us to establish a strong U.S. presence, including dedicated sales resources and consultants.
