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Search Spec Compliance , found 4 results

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FDA Device Regulation Consultant

fda-consultant-specialist

alirezarezvani/claude-skills

Provides FDA regulatory consulting for medical device makers, covering pathway choice (510(k)/PMA/De Novo), QSR compliance, HIPAA readiness, and device cybersecurity guidance when preparing submissions or responding to agency inquiries.

EU MDR Compliance Specialist

mdr-745-specialist

alirezarezvani/claude-skills

Guides teams through EU MDR 2017/745 requirements for device classification, technical documentation, clinical evaluation and post-market surveillance, including Annex workflows, EUDAMED/UDI integration, and Notified Body interactions.

Niche Intelligence Strategist

20-andruia-niche-intelligence

sickn33/antigravity-awesome-skills

Niche Intelligence Strategist injects industry-specific regulations, compliance gates, tech stacks, and UX norms after a project’s vertical is defined, delivering dossiers that align product, design, and engineering teams around a sharp domain understanding.

Global Odoo Compliance

odoo-l10n-compliance

sickn33/antigravity-awesome-skills

Guides installing Odoo localization modules, configuring country-specific taxes, fiscal positions, e-invoicing (CFDI, FatturaPA, SAF-T), and reports so companies meet local compliance requirements.

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