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  • Where did FDA 510 (K) form 3654 go? - The Elsmar Cove Quality Forum
    I am doing a new 510(k) and wanted to make sure I'm using the latest version of form 3654 but it seems to be gone Anyone know anything about it? It isn't in the forms list anymore FDA Forms
  • Any experience on filling form, FDA 3654 for the DICOM standard?
    Re: Fill out FDA 3654 for the DICOM standard? The form is generic and is only two pages long Complete this as you would for any other applied standard
  • How to use FDA Form 3654 - The Elsmar Cove Quality Forum
    My take on the 3 sections on page 2 of FDA form 3654 is that it is a place to list deviations or options Presumably the FDA doesn't expect too many of these for each standard
  • ASQ Green Belt E-Learning is a Scam? - Page 2 - The Elsmar Cove Quality . . .
    I feel like I've been scammed by ASQ ASQ will not give refunds for e-learning modules after they've been started I assumed that $1,500 was buying me some top-notch training but the e-learning module is rife with technical problems, simplistic to the point of useless info, and I doubt some of
  • Dating controlled documents after changes - Revision History
    During an audit I got questions from the auditor about the dates in our revision histories For example I had an engineer update a document on January 10th 2020 and that's the date that he had in the revision history Then when I approved the document and placed it in the released folder, I
  • List of NCR (NonConformance Report) Defect Cause Corrective Action Codes
    We are developing an on-line non-conformance reporting (NCR) system to capture all defects found, their root cause and corrective action We need to assign and insert codes for defects, causes and corrective actions to make the data usable to spot trends and systemic problems Our
  • Declarations of conformity and summary reports
    Hello everyone, I am preparing my tradditional 510(k), until the 9th part for 510(k),I find the declarations of conformity requirement and in the guidance document,it says the declarations of conformity is for abbreviated 510(k)s So I want to know if I should submit declarations of conformity
  • Pallet Pattern for EtO Sterilization method
    Hello, I’m new to the FDA-regulated industry and am currently working on developing a pallet pattern for EtO sterilization for our medical device I wanted to reach out for guidance and best practices regarding pallet pattern design for EtO We will not be using wooden pallets, and the load
  • Definition - Rework vs. Repair in ISO AS9100 - The Elsmar Cove Quality . . .
    Hello all, I am in the unfortunate position of having to verify my definitions of these terms to our new Operations Manager I, like most others in the ISO AS world (I'm in aerospace) use the following "quick and dirty" definitions REWORK: Meets all specs REPAIR: Doesn't meet all specs, but
  • Safe Launch Plan (SLP) - Seeking Example Procedure
    Can somebody send me a procedure for executing of Safe launch plan (SLP)? SLP is implemented to verify product process stability in an organized manner SLP is also intended to be a learning period Collected data will be monitored, analyzed and product process adjustments should be made





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