Agent Skills Directory

Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.

Run a compliance check on a proposed action, product feature, or business initiative, surfacing applicable regulations, required approvals, and risk areas. Use when launching a feature that touches personal data, when marketing or product proposes something with regulatory implications, or when you need to know which approvals and jurisdictional requirements apply before proceeding.

GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests. Use for GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, and data subject rights management.

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.

Generate a response to a common legal inquiry using configured templates, with built-in escalation checks for situations that shouldn't use a templated reply. Use when responding to data subject requests, litigation hold notices, vendor legal questions, NDA requests from business teams, or subpoenas.

FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

Generate contextual briefings for legal work — daily summary, topic research, or incident response. Use when starting your day and need a scan of legal-relevant items across email, calendar, and contracts, when researching a specific legal question across internal sources, or when a developing situation (data breach, litigation threat, regulatory inquiry) needs rapid context.

Atlassian Template and Files Creator/Modifier expert for creating, modifying, and managing Jira and Confluence templates, blueprints, custom layouts, reusable components, and standardized content structures. Use when building org-wide templates, custom blueprints, page layouts, and automated content generation.

Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.

Atlassian Administrator for managing and organizing Atlassian products (Jira, Confluence, Bitbucket, Trello), users, permissions, security, integrations, system configuration, and org-wide governance. Use when asked to add users to Jira, change Confluence permissions, configure access control, update admin settings, manage Atlassian groups, set up SSO, install marketplace apps, review security policies, or handle any org-wide Atlassian administration task.

Atlassian Confluence expert for creating and managing spaces, knowledge bases, and documentation. Configures space permissions and hierarchies, creates page templates with macros, sets up documentation taxonomies, designs page layouts, and manages content governance. Use when users need to build or restructure a Confluence space, design page hierarchies with permission structures, author or standardise documentation templates, embed Jira reports in pages, run knowledge base audits, or establish documentation standards and collaborative workflows.

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.