Experience Counts.

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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Med Tech News

by AdvaMed SmartBrief

Device tax could add $175M to Medtronic's annual costs, exec says
 
The proposed 2.3% medical device excise tax set to begin next year will cost Medtronic $125 million to $175 million a year, s -More

CAPA Violations Still the Top Issue for FDA: FDA inspectors view a firm's CAPA program as an indicator of how well or how poorly a firm has a handle on its overall operations. Read more...

SafeStitch Medical lands $8.3 million from stock placement
 
Miami-based SafeStitch Medical, a maker of devices for endoscopic and minimally invasive procedures, has raised $8.3 million  -More
Global demand for pacemakers fuels profit growth for Medtronic
 
Medtronic posted a 1.2% growth in profits during the company's fiscal third quarter that ended Jan. 27.  -More
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