We specialize in innovative software solutions crafted for regulated sectors, with a primary focus on MedTech.
BrightHills has over two decades of experience developing custom software for international clients with a key focus on medical device software, banking, and finance. From the outset, the company has emphasized a collaborative environment and people-centric approach that guides our decisions, whether in staffing, client relationships, or engineering solutions geared towards meeting user needs.
Working in demanding quality-oriented industries has allowed us to acquire skills and knowledge we are eager to share with our clients, facilitating mutual improvement and growth. We have found that this is key to establishing enduring partnerships. Acknowledging the diverse needs and challenges our clients encounter, we invest considerable effort into understanding their business requirements before crafting custom solutions. This approach ensures that our high-quality solutions not only align with client needs and expectations but also adhere to industry regulations.
Innovation and continuous improvement are ingrained in the BrightHills mindset. By staying on top of technological trends, we provide our clients with solutions that allow them to outpace their competition.
At BrightHills, we aim to play a pivotal role, whether as software developers, solution providers, or consultants, ensuring our clients not only succeed but also shape the future of their industries.
Our Mission
Empowering regulated industries through our knowledge, people-centric mindset and commitment to improve in a collaborative environment, to craft software solutions that transform the future.
Our Vision
Guiding quality-oriented industries into a tech-driven future.
Our Areas of Expertise
- Extensive experience (18+ years) developing software as a medical device solutions (SaMD)
- Regulatory teams experienced in both US FDA 510(k) and EU MDR (CE marking). We have guided clients in 12 successful 510(k) submissions, with 80 days as the quickest turnaround
- Coverage of complete Software Development Lifecycle (SDLC) from prototyping through Development, Quality Assurance, Testing and Regulatory Affairs to multi-lingual Support (Tier 1-3) and Technical Documentation
- Experienced in drafting Standard Operating Procedures (SOPs) and setting up appropriate Quality Management Systems (QMS)
- Specialized knowledge including Big Data, Business Intelligence, Machine Learning and AI
