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Software as a Medical Device is shaping the landscape of digital therapeutics (DTx)— an area that is evolving along with the regulation that guides it.
Although SaMD isn’t a physical product that requires manufacturing, regulatory guidelines and review timelines are consistent with traditional medical devices. You must provide clinical validation/evaluation to show the safety and efficacy of your product to the FDA.
To ensure your product gets market access, you need a CRO knowledgeable in regulatory compliance, specifically as it relates to SaMD.
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The Right Fit
For Any Company
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The Right Fit
For Any Size
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The Right Fit
For Your Company
You need an agile CRO that knows the FDA’s preferences and expectations.
We provide a specialized service tailored to meet your needs as a company. We know how to support our clients. We can help you navigate the process with ease, lightening your workload while paving the path to approval.
SaMD - The Intersection Between Tech & Health
SaMD is bringing healthcare through a digital transformation.
AI & Machine Learning are providing new and exciting opportunities in digital health. From imaging devices to robotics, the treatment and diagnosis of specific disease conditions are now available as primary options due to the emergence of SaMD.
The differences between physical products and software make the approval process for software more complex— the regulation is rigorous.
Our clients come to us with a wide range of experience in developing medical products. We are committed to helping companies of all sizes, and we have an extensive history of working with emerging companies.
Matt Garrity
Director Of Quality
Riva Health
I consider myself quite lucky that when I started as Director of Quality at our innovative SaMD start-up, we already were working with Proxima and Ellie Reynolds.
"It was invaluable to me to have a knowledgeable, collaborative and responsive partner in Ellie to help me build our QMS and to provide hands-on training in our eQMS, Greenlight Guru. Another great benefit of partnering with Proxima was that when extra help or expertise was required, Ellie always was quick to connect me with other resources on the Proxima team."
