Documentation Successful 510 (k) Documentation for Software or Software Containing Medical Devices
Duration : 60 Minutes
Nancy Knettell,
Nancy Knettell, Founder and Principal at Software510K, LLC, has over 30 years in combined Mechanical Design, Software Development, and Regulatory experience primarily in the Medical Device industry working with such major medical device companies such as Smith and Nephew, Philips Medical, CR Bard, Read more
One of the main reasons that submitting a 510K for software enabled medical devices or software as a Medical Device can fail to get approval by the FDA is due to deficient or missing documentation. Despite a long history of software usage in medical devices, there is significant confusion regarding updating software applications in new 510(k) devices and the additional testing requirements. This course will describe what the FDA is expecting in the 510K submittal and how to make sure that the documentation meets those expectations.
Why Should You Attend:
This course is essential for medical device companies interested in submitting software enabled medical Devices or Software as a medical device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant.
Course Outline:
• Know exactly what software documentation needs to be prepared for a Class II/B/moderate level of concern for the software portion
• Know 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 510K approval
• Avoid potential audit risks and serious findings post submittal that can block their ability to ultimately sell their product successfully
• Know what is expected to have in place for compliance for your company during the preparation of a 510K to prevent this risk
• Ensure a faster 510K approval because the documentation is complete and comprehensive
• Prevent costly time to market issues because 510K has been rejected completely because of software
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Medical Device Software Regulatory professionals
• Medical Device Software Quality Assurance Engineers
• Medical Device Software Quality Senior Management
• Medical Device Software Company Senior Management
• Medical Device Quality Engineers
• Medical Device Quality Senior Management
• Medical Device IT
• Medical Device Software developers
• Medical Device Management
• Software validation engineers
• Manufacturers of medical devices
• Product Development managers
• Regulatory managers
• Project managers and documentation specialists
• Medical writers
• Medical device IT specialists
• Medical device and 510(k) consultants
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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