SARACA reduces CER development time by up to 40% with best practices tracker tool

eTradeWire News/10579548
Growing experience producing Clinical Evaluation Report updates leads to highly-effective and cost-efficient methods that benefits clients

FAIR PLAY, S.C. - eTradeWire -- After producing more than 100 Clinical Evaluation Reports for medical device companies during the last three years, Saraca Solutions has developed a tracking tool that supports reducing the time it takes to create an update using new standards by up to 40% -- while remaining highly effective and cost efficient for clients.

"Our team's deep experience in international medical device regulatory issues has led to creating these best practices for the benefit of our clients who depend upon us for this reporting compliance," said Kuldeep Tyagi, CEO and managing director of Saraca Solutions. "A number of companies we work with invested time and money into this process but turned to us to help complete them as they were challenged by interpretation of the standards. These companies found us much more effective and cost-efficient which lead to repeat business."

Saraca Solutions, he said, developed a method of grouping specific experts to collaborate. This led to the development of a unique AI-based tool that automates some of the research and collection work, particularly for relevant article searches, which reduces tasks that typically take nearly 15 hours down to about one hour.

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A CER documents conclusions for a medical device's clinical evaluation and consists of analyzed clinical data collected from either investigation of a company's device or studies of substantially equivalent devices. Required for all medical devices marketed in Europe, the CER demonstrates that the device achieves its intended purposes without additional risk.

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For more information, contact:

Kevin J. Berger, Head of Marketing


Skype: kevinjberger


Kuldeep Tyagi, CEO and Managing Director

+1-901-286-1890, +91-9711612068

Skype: tyagi_k75

Kevin Berger
Saraca Solutions

Source: Saraca Solutions
Filed Under: Engineering

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