Closing the Gap - Intertek

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For more information about Intertek s Testing and Certification capabilities, please contact Intertek at 1-800-WORLDLAB, email or visit our website at Closing the Gap Understanding the Software 510(k) Review Process Closing the Gap: Understanding the Software 510(k) Review Process 1Introduction The creation of quality medical software is a challenge to the medical device industry. Getting a medical device cleared through the FDA premarket 510(k) approval process can be just as challenging, especially if it has software included. The role of software in medical devices has evolved to encompass more and more functionality. devices that were previously seen as quite rudimentary are now including software for more critical functionality. The medical device industry is slowly moving toward higher levels of features, networking, data gathering, imaging, and diagnostic functions. The complexity is growing from the most complex radiological devices all the way down to the infrared heat lamp.

Closing the Gap: Understanding the Software 510(k) Review Process www.intertek.com/510k 3 was “burdened” in the way that it caused delays in getting new medical devices to market.

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