Accelerate the development of innovative, compliant medical devices, healthcare platforms and applications to elevate patient care and optimize efficiency.
We specialize in designing and developing cutting-edge digital tools tailored to the unique needs and requirements of the healthcare industry, from Software as a Medical Device (SaMD) and AI to Digital Transformation and E-Prescription.
Healthcare trusts Quantiva.
Our Expertise in Healthcare Solutions
Software as a Medical Device (SaMD)
We create compliant AI-powered SaMD solutions. Quantiva accelerates and streamlines the development process.
We can integrate with your team and ensure your medical device software meets regulatory standards without compromising innovation.
FDA 510(k) Preparation
Navigate the FDA 510(k) process with confidence through Quantiva's comprehensive support.
Our team collaborates with you on quality management frameworks, documentation, and joint 510(k) package preparation for smoother FDA approval.
Cloud Compliance for GxP & HIPAA
Quantiva helps healthcare organizations seamlessly transition to the cloud while maintaining GxP and HIPAA compliance.
Our cloud-agnostic approach enables secure data management across platforms such as AWS, MicrosoftAzure, and Google Cloud.
E-Prescription
Quantiva designs and implements SureScriptscertified e-prescription systems, ensuring secure, reliable, and efficient prescription management.
Improve patient safety and experience with our advanced electronic prescribing expertise.
Digital Transformation
Boost operational efficiency and patient satisfaction through Quantiva's process improvement services.
We assist vendors and healthcare providers in automating and streamlining critical processes. This includes the deployment of solutions based on SMART on FHIR.
6 Months
Number of hours of manual work we saved for our clients.
99.99%
Uptime of our automated processes.
1 hour
Average time it takes us to assess automation potential
What our clients say
“Outstanding Partner”
The professionals at Quantiva have been an integral part of our success.
Steve Owens – CEO
“Quantiva helps us save cost and scale”
Now, they’re helping to integrate technology from our latest acquisition
Michael Goerner – CIO
“Great Team”
The Quantiva team worked closely with us to tailor their technical effort to our business needs.
Ryan DeMent – CEO
“Amazing Partnership”
We started working with Quantiva a few years ago. It's been working out extremely well.
Veer Vikar – Manager
Case Study We deliver impact
FDA 510k clearance within months
AI powered Software as a Medical Device (SAMD)
Client
UPenn / Quantaras
Client Challenge
Prototype code of an AI to auto-contour organs at risk
Need to obtain FDA 510k clearance
Our Solution
Supported creation of quality system
Established algorithm change protocol to allow compliance with FDA regulation
Architected & implemented compliant, auto-scalable system in the cloud
Reduced operating costs by 66%
Results
Obtained FDA 510k clearance
Ability to operate test, demo and production environments at manageable cost.
...and many more upon request
Accelerate your time-to-market and de-risk your product development.
You don't have to trade compliance for time-to-market and rapid execution. Our team of seasoned professionals excels in delivering solutions that seamlessly combine regulatory compliance with accelerated development timelines.
By leveraging our deep industry knowledge and best practices, we help organizations navigate complex regulations without sacrificing innovation or efficiency.