Pdf Creator

Grow a component package into a high-quality, sourceable reusable design in Zener. Use when translating a datasheet, application note, or eval design into circuitry that should live with the component package itself — including checking for existing reusable packages first, extracting evidence, choosing sourceable passives, documenting the design in the `.zen` docstring, and validating with `pcb build`.

Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.

Transcribe audio and video files to text using OpenAI Whisper. Use when: converting podcasts to blog posts; creating video subtitles; extracting quotes from interviews; repurposing video content to text; building searchable audio archives

Guide users through obtaining and configuring a Vapi API key. Use when the user needs to set up Vapi, when API calls fail due to missing keys, or when the user mentions needing access to Vapi's voice AI platform.

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.

Corrects speech-to-text transcription errors using dictionary rules and Claude's built-in AI (no external API key required — Native AI Correction is the DEFAULT). Stage 3 API is a backup for automation without Claude Code. Builds personalized correction databases that learn from each fix, auto-loads person-name ASR variants from your people roster, and reads per-domain context files that prime the AI pass for context-dependent homophones. Triggers when working with ASR/STT output containing recognition errors, homophones, garbled technical terms, person-name errors, or Chinese/English mixed content. Also triggers on requests to clean up meeting notes, lecture transcripts, interview recordings, or any text produced by speech recognition. Use this skill even when the user just says "fix this transcript", "clean up these meeting notes", or mentions garbled names without invoking ASR specifically.