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JP Med Design
Risk Management
You are staring at a blank spreadsheet page with "FMEA" at the top, and you know you need to get organized. Risk management work seems like a long, painful, messy process that ends up as a page in a folder, rather than a tool for guiding testing and validation.
FMEA can in fact be a powerful tool to guide your design, process instructions, and V&V planning, but it rarely seems to live up to that promise - I can help.
I can review your design while your team continues their work and deliver a draft FMEA that meets your RM procedure requirements, is organized, consistent, and partially automated to reduce errors. I can review it with your team to finalize it, and help you document the output of the process and how it connects to your V&V testing, and your process instructions.
Better still, I can help re-vamp your RM process, acting as the voice of R&D, working with your quality group to make your FMEA's easy to use tools that help focus your development process, and wow the auditors.