BrightHills

At BrightHills, we bring over 20 years of MedTech experience to the table, providing comprehensive and innovative software solutions that meet the highest regulatory and quality standards. Our 150+ colleagues have completed 400+ projects in both the EU and the U.S., including Haemonetics, GPI, Inlog, SMART Respiratory and more.

Our Services Span the Entire Spectrum of Medical Software Development:

• Software as a Medical Device (SaMD)

We specialize in the complete journey of SaMD projects, from the initial idea to the end-user, ensuring that every step meets stringent regulatory requirements and delivers exceptional quality.

• Standard Operating Procedures (SOPs)

We offer tailored SOPs that enhance each stage of your Software Development Life Cycle. Our customized procedures streamline your processes, ensuring efficiency and compliance.

• Flexible and Scalable Teams

We understand that every project is unique. That's why we offer scalable, flexible teams tailored to your specific needs, allowing you to pay only for the exact number of Full-Time Equivalents (FTEs) required.

Our Services Include:

• Product Design - We ensure your product's design meets all necessary regulatory requirements, providing a solid foundation for development and compliance.
• Software Development - Whether you need a full development solution or support for specific project aspects, our flexible services are designed to meet your needs.
• Testing - Improve your product quality with our state-of-the-art testing methodologies, including automated and AI-driven tools, ensuring your product is market-ready.
• Support - Our support services ensure your operations run smoothly and efficiently, addressing any issues promptly.
• MedTech Consultation - We guide you through U.S. FDA and EU MDR regulations, securing 510(k) clearances and CE marking. Our expertise in regulatory strategy, post-market surveillance, and ISO certifications ensures successful market entry and ongoing compliance.
• Team Augmentation - Enhance your capabilities with our skilled professionals who integrate seamlessly with your team, providing additional expertise and capacity.

We help you achieve faster, more efficient, and error-free releases.

Let’s connect!

BrightHills Team