Understanding the Software 510(k) Review Process

As experts in the FDA review process, Intertek is the medical device industry’s leader in providing education and guidance throughout the complex path to 510(k) approvals. Intertek’s latest 20-page white paper, Closing the Gap: Understanding the Software 510(k) Review Process, provides in-depth guidance for devices containing software, and includes software documentation overviews and descriptions, device hazard analyses, software requirements specifications (SRS), and more.

Please provide the following information to receive the free white paper download: