510(k) Documentation Best Practices for Software or Software Enabled Medical Devices

Why Should You Attend:

Software enabled Medical Devices or Software as a Medical Device can take years to develop not to mention the high cost of developing it due to high value resources such as Software Developers. Often it can take seven months once a 510K is submitted to find out that your software documentation was not acceptable to the FDA and your approval is denied. Once the product has been cleared and put on the market, post Market audits can put a company in line for serious findings if they are found not compliant to expected Standards.

This training will remove the mystery of what are the documents that are required to be submitted to ensure a favorable 510K. How to set up the development and documentation environment so that you are compliant to the FDA Requirements and your Medical Device Software documentation does not block your submittal.

This training will also show you how to prevent serious Post Market audit findings that can cause your company serious economic risk.

Areas Covered in the Webinar:

• Why is Compliance to IEC62304 essential to preparing software documentation to submit successfully to the FDA for a 510K ?
• What specific documentation is required for Class B Medical Device Software for submittal?
• What Constitutes Compliance.
• The Key Guidance that the FDA is expecting to be followed within the Software Development and Verification/Validation Process.
• What documentation is required to support different Classes of Medical Device Software ?
• Setting up Design Development Documentation correctly to ensure compliance to the standard.
• What are the serious legal risks to the Company in not ensuring Compliance with Post Market audits?

Who Will Benefit:

• Vice President of Quality Assurance Medical Devices
• Software Quality Manager Medical Devices
• Software Engineering Manager Medical Devices
• Software Quality Engineer Medical devices
• Vice President of Regulatory Affairs
• Director of Quality Assurance Medical Devices
• Software Engineer Medical Devices
• Regulatory Affairs Personnel
• Quality Manager Medical Devices

Nancy Knettell
Principal, Signet Medical Systems

Nancy Knettell, Founder and Principal at Signet Medical Systems, LLC, has over 30 years in combined mechanical design, software development, and systems engineering experience primarily in the medical device industry as a Software Verification, Validation/Systems Engineer.

Along with her senior level management experience with cross-functional program teams for major companies such as EMC and United Technologies, Nancy has also consulted to major medical companies such as Smith and Nephew, Philips Medical, CR Bard, Kollsman Medical, Applied Biosystems, Deka Research, Avedro and Hologic.

But, for Nancy, involvement in medical device development is a personal issue. Having lost her father at an early age to heart disease, she now wants to work to help other people facing such life threatening events. It is her mission to advance the potential for life-saving medical devices through the use of quality based engineering systems.

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