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.

White Paper
Medical Device White Paper: Best Practices for Interventional Cardiovascular Medical Device Trials
           
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Med Tech News

by AdvaMed SmartBrief

St. Jude earns CE mark for next-gen heart ablation device
 
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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.
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J&J's $5B share repurchase program wins board approval
 
A plan by Johnson & Johnson to buy back as much as $5 billion of its stock has been approved by the company's board.  -More
First tranche of Trice Medical's $11.6M funding round completed
 
Trice Medical has completed the first part of its Series B funding round aiming for $11.6 million.  -More
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