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HEALTHCARE


ACCELERATE AND STAY COMPLIANT.

Accelerate the development of innovative, compliant medical devices, healthcare
platforms and applications to elevate patient care and optimize efficiency.
Let's have a chat



WHY CHOOSE QUANTIVA FOR HEALTHCARE SOLUTIONS?

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, Microsoft Azure, and Google Cloud.

E-PRESCRIPTION

Quantiva designs and implements SureScripts certified 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.

BENEFITS

Here are some of the benefits our clients see
Expert Guidance to Maximize Efficiency
Risk Mitigation and Compliance Support
Seamless Integration and Scalability
End-to-End Support for Success

LET US ACCELERATE YOUR GROWTH.

GET IN TOUCH WITH US TODAY!

Let's have a chat
Wunderkind LLC dba Quantiva - 520 White Plains Rd. Ste 500, Tarrytown, NY, 10591
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