Medical Device Mdr Auditor

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• Adverse Event NarrativeGenerates CIOMS I-compliant adverse event narratives.
• Clinical Data CleanerCleans and standardizes clini.
• Ectd Xml CompilerConverts drug application documents into an eCTD-compliant XML skeleton.
• Irb Application AssistantAssists with IRB applications and reviews.
• Patent AssistantAssists R&D teams with patent technical disclosure drafting and patent/novelty search.
• Phi Prompt GuardGuards prompts against exposing protected health information.
• Protocol Deviation ClassifierClassifies clinical trial deviations.
• Regulatory SubmissionPrepares FDA and EMA drug submissions in CTD format with module outlines.