“I could not have asked for a better partner to develop our EKG monitoring solution. Orthogonal helped us make good choices, execute with speed and quality, and navigate our 510(k) clearance.”
Case Study
Venture-Backed Startups
Build Your Product Right
The First Time
Leverage our deep Software as a Medical Device and connected device experience to build game-changing medical device systems.
Meet funding deadlines,
hit clinical milestones,
build a great product.
You have a proof-of-concept for your device, and you’ve secured funding to get to your next milestone – such as a clinical trial or regulatory filing. That funding will help bring your device online, enabling the creation of engaging mobile apps, integrated AI algorithms and a reliable and secure cloud backend. But now you have your next looming deadline. With so much on the line, you can’t afford to waste time and money on unnecessary detours.
Orthogonal empowers you to meet your deadline head-on. Using our decade of experience with developing connected medical device systems, we’ll help you apply quality processes designed for SaMD, manage validation for a BYOD environment and tackle integration between hardware and software – all while keeping your development on time and on track.
We’ve worked through the hardest parts of medical device software development over dozens of projects, including regulatory strategy, Bluetooth integration and software segregation. We’ll work together with your team to manage core challenges in a timely and cost-effective manner, allowing you to hit your milestones and launch a successful product.
What Our Clients Say
“Orthogonal brought us the expertise we needed to ensure our technology platform met the high standards of the FDA. Through their involvement, we absolutely accelerated our pace through the regulatory process. ”
Case Studies
Case Study
