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.

Closing the Gap: Understanding the Software 510(k) Review Process www.intertek.com/510k 2 conceptual, documental, procedural parts malfunctions there could be costly and

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