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

This course on 510K documentation for software or software enabled device will detail what Medical Device companies need to know what Software Specific documentation needs to be prepared for successful 510K submittals to avoid delays or denial of the 510K approval. it will discuss key to comply with IEC62304, FDA guidance with in software development and verification/validation process.

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.