2011 Medical Device Outlook Report

April 5, 2011

By Sparta Editorial


Ensure Medical Device Quality and Regulatory Compliance

Recently, Sparta Systems contributed to PharmaLive.com’s 2011 Special report about Medical Devices.  Click here to view the full article.  Our Industry Principal, Tim Mohn, offered some insightful perspectives about the medical device industry; what’s changing and trends we expect to see in the future.  Tim also offers companies an interesting perspective as they work to understand the business benefit for deploying EQMS by tying it directly to new product development and the 510(k) process.  After all, many design changes are actually driven by CAPA, which in turn comes from manufacturing nonconformances and customer complaints, and companies that fail to escalate the right items to CAPA will fail to generate the optimal next-generation device.  What good are efficient design changes if you are changing the wrong thing?

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