Your Allies in Medtech

At our core, we value people.

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.


Our team manages the entire medical device software lifecycle including planning, analysis, development, testing, support, documentation, and ensuring compliance with regulatory requirements.

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.

Full lifecycle custom software development for medical software (Class I, II, III / A, B, C)
Regulatory compliance with FDA 21 CFR Part 820, ISO 13485, IEC 62304, EU MDR
Compiling 510(k) documentation
Comprehensive CE marking guidance
Drafting standard operating procedures (SOPs)


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.


We get existing deliverable packages ready for streamlined evaluation by identifying gaps and suggesting ways documentation can be improved.


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.


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.


In response to COVID-19, Dentalive emerged as a teledentistry solution, revolutionizing patient care.

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.

Product Design
Software Development

Smart Peak Flow

Originating as a Kickstarter project, Smart Peak Flow has later evolved into a successful startup addressing asthma management.

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.

Product Design
Quality Assurance


Our web-based software solution adheres to international standards, facilitating the entire journey of blood products from donation to transfusion across more than 50 countries.

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.

Product Design
Quality Assurance


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.

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Bela Venesz Dr.HQ Hungary+36 20 468 9806
Nathaniel SandysU.S.+1 612 743 9103
Stevie FarkasDACH+43 677 6299 0045


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