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Medical Device Development
Don’t Get Put Into a Square Hole.
As a development company maneuvering your medical device through the pipeline, you may have found that your outsourcing providers don’t really understand the difference between a 510(k) and an NDA. We do.
Novella Clinical provides a unique approach and understanding of small and large sponsors in the medical device arena. Simply taking a drug development mentality and applying it to a device program is unfortunately too often the case.
Novella Clinical has a full understanding of your special device requirements, including study design, regulatory, language nuances and the staffing expertise needed. Since 2000 we have successfully conducted, and are currently implementing, a multitude of Class II and Class III device programs:
428 Device CRAs (through Novella Clinical Resourcing)
We have 607 candidates with device experience out of a pool of 1654, or 37% of our database.
Our device experience includes, but is not limited to:
AAA Stent
Carotoid Stent
Coronary Stent
IUD
Pacemaker
Renal Device
Vascular Stent
Certified Quality
We don't just say quality... we prove it.
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