Dedicated Expertise.

Medical device companies are facing more challenges than ever. A changing regulatory landscape makes bringing devices and diagnostics to market difficult; planning missteps cost you time and money. Each day Novella Clinical helps device, diagnostic and drug/device combination sponsors navigate regulatory hurdles and provides guidance from regulatory assessments to post-marketing strategies.

But perhaps the most satisfying work lies in between – designing and executing clinical trials. As one of the largest CROs supporting medical device sponsors, Novella has the global footprint and clinical depth to expertly guide you through the clinical trial process, resulting in the clinical data critical to moving your product forward. 

And for over a decade we have been helping sponsors do just that – bring products to those who need them. Although our clinical experience is all-inclusive, our therapeutic concentrations for device and diagnostics include cardio/vascular, orthopedic/spine, general surgery and oncology.

Novella is proud to have earned preferred vendor status with two of the top five medical device companies due to our outstanding operational execution, quality management program including ISO 9001:2008 certification, and superior client satisfaction ratings.

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Medical Device White Paper: Clarifying the Regulatory Road for Combination Products
           
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Med Tech News

by AdvaMed SmartBrief

Abbott's coronary stent clears regulatory hurdle in Europe
 
Regulators in Europe have granted Abbott approval to market its Xience Xpedition 48 system, which the company says is the "lo -More
Maquet acquires maker of cardiac closure device
 
Maquet Cardiovascular has agreed to buy LAAx for undisclosed terms.  -More
Texas device-maker obtains $12M in funding round
 
A round of financing from six backers has pulled in $12 million for Inova Labs.  -More
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