Is Your Medical Device Software 510(k) Ready? - 2018

Topics

• What is required to have in place for Quality Systems to ensure your Software submission will be accepted for approval by the FDA for review to prevent costly time to market delays
• Pertinent and required Guidances that the FDA Recognizes in support of submitting a 510(k) for software
• How to ensure the software documentation is prepared correctly specifically for the software portion of the submittal so that it will be in compliance preventing delays of the 510(k) approval
• Exactly what software documentation needs to be prepared and how for a Class II/B/Moderate Level of Concern for the Software Portion to ensure
• What is expected to have in place for compliance for your company during the preparation of a 510(k) to prevent this risk
• Potential audit risks and serious findings post submittal that can block their ability to ultimately sell their product successfully
• Costly time to market issues because 510(k) has been rejected completely because of software
• A faster 510(k) approval because the documentation is complete and comprehensive