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.

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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