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510(k) Project Management - Updated for 2021

This webinar was recorded twice previously by Rob Packard, but the webinar was finally updated for the first time since we hired full-time employees (i.e. Mary Vater) in 2017. Working as a team of 510(k) consultants on submissions has taught us a lot about project management, and the recent challenges of the Covid-19 pandemic have forced us to be creative and figure out how to be successful with 510(k) submissions without the ability to conduct pre-submission meetings in a timely manner. In the 2021 update, Matthew Walker presented a couple of slides that explain the ten quality tasks that you need to complete in parallel with the preparation of your 510(k) submission. He also introduced the concept of the "trinity" of quality system processes: 1) risk management, 2) usability, and 3) cybersecurity. Medtech companies of the future will succeed or fail by mastering the convergence of these three processes. Next, Meri Martinez shared some of her lessons learned from the first seven months of working as a regulatory affairs consultant. She shared the importance of including each of the previous submission document numbers in your cover letter. She also explained that you need to provide copies of previous deficiency letters and a response memo that addresses each of those deficiencies. Next Meri explained the five different methods she uses to make sure that she has identified all of the relevant guidance documents. Rob Packard talked about how Medical Device Academy creates testing plans at the beginning of every project--sometimes before we even have a device description. Bhoomika Joyappa explained how she uses the testing plans to determine if medical device companies have completed all required testing before she even begins preparing a 510(k). Sharon Morrow and Rob Packard explained how device companies submitting face masks have learned the hard way that they need to plan ahead to make sure that validation batches are exactly the right size to optimize the number of units in a batch to meet the minimum requirements for sample sizes. Mary Vater described the table of contents template that our firm uses--including color-coding to indicate the status of each requirement. The use of notes in red font was demonstrated for identifying updates. Mary also gave us a simple tip for communicating roles and responsibilities for everyone on your development team. The process for determining substantial equivalence and the FDA decision tree was illustrated in detail, and Meri Martinez told us how Mary Vater trained her to start each project by completing the SE comparison table to isolate any gaps in the 510(k) submissions strategy. The presentation came to a close with a comprehensive review of which protocols and supporting documents should be included in a pre-submission meeting request to provide the FDA with a complete understanding of your testing plan. This insight is crucial to understand, because otherwise the FDA cannot identify potential problems with your testing plan that might result in delayed 510(k) clearance.