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    regulatory affairs head

    1

    Expert regulatory strategy and submission planning for MedTech, HealthTech, and medical device compliance.

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    regulatory affairs head

    regulatory affairs head

    Example session with this skill installed

    Compare the regulatory pathways for a Class IIa AI-driven ECG analysis software entering the US and EU markets. We have ISO 13485 certification and early clinical pilot data.

    • Read your context and instructions
    • Compiled the regulatory affairs head
    • Generated the document

    I have analyzed the regulatory landscape for your AI-driven ECG analysis software. This comparison assumes the software qualifies as Class IIa under EU MDR Rule 11 and maps to a Class II FDA product code.

    Regulatory Pathway Comparison: AI ECG Analysis Software

    FeatureUS Market (FDA)EU Market (MDR)
    Primary Pathway510(k) Premarket NotificationAnnex IX/X Conformity Assessment
    ClassificationClass II (Potential Code: QAS)Class IIa (Rule 11)
    Predicate/RuleRequires substantial equivalence to a cleared device.Requires compliance with General Safety and Performance Requirements (GSPR).
    Evidence BasisClinical performance data + Cybersecurity documentation.Clinical Evaluation Report (CER) + Post-Market Surveillance (PMS) plan.
    Review BodyFDA (Center for Devices and Radiological Health)Notified Body (e.g., BSI, TÜV SÜD)
    Estimated Timeline90-180 days (FDA review time)9-15 months (NB backlog dependent)
    Key RiskFinding a suitable predicate for AI algorithms.Stricter clinical evidence requirements under MDR.

    Strategic Recommendation

    Pursue

    FDA 510(k) as the lead market if a clear predicate for ECG analysis exists, as the timeline is currently more predictable than EU Notified Body queues. Simultaneously, leverage ISO 13485 audits to prepare the Technical Documentation for EU submission.

    Next steps

    1. Identify 2-3 specific FDA predicate devices to confirm "Substantial Equivalence" strategy.
    2. Initiate a GAP analysis between current clinical pilot data and EU MDR Clinical Evaluation requirements.
    3. Confirm Notified Body availability and current lead times for software-specific audits.

    regulatory-affairs-head.pdf

    PDF · document

    Generated

    Example file from a real run - the skill writes it into your workspace.

    Connects securely to your tools. The creator never sees your data.

    What you get

    Generate pathway comparison matrices for FDA and EU MDR submissions.Build regulatory milestone plans with dependency and risk mapping.Conduct submission readiness reviews for technical documentation.Prepare executive regulatory reporting packs for management reviews.

    About this skill

    The problem

    MedTech and HealthTech teams often struggle to map complex regulatory requirements to specific product features, leading to delayed market access and submission rejections. Manually tracking global pathway dependencies and submission readiness is prone to error and can result in costly compliance gaps.

    What it does

    • Generates structured regulatory strategies for medical devices, software, and HealthTech platforms.
    • Compares global regulatory pathways including FDA 510(k), De Novo, PMA, and EU MDR conformity routes.
    • Builds submission plans with milestone maps, dependency tracking, and risk registers.
    • Produces regulatory intelligence briefings and change impact assessments for management review.
    • Assesses compliance programme maturity and data governance frameworks for regulatory reporting.

    Frameworks & tools

    Supports compliance workflows for FDA (21 CFR), EU MDR, ISO 13485, and ISO 14971 standards.

    Why this beats prompting it yourself

    General-purpose prompts often miss the critical distinction between regulatory strategy and legal advice, or fail to account for technical data governance. This skill enforces quality gates that mandate evidence-based assumptions and explicit risk-owner mapping, ensuring outputs are decision-ready for executives.

    Use cases

    • Comparing FDA 510(k) vs. De Novo pathways for a novel AI diagnostic tool.
    • Sequencing a global market access plan across EU, US, and APAC markets.
    • Conducting a submission readiness review before a formal EU MDR technical file audit.
    • Creating a regulatory impact assessment for a major software-as-a-medical-device (SaMD) architecture change.

    Known limitations

    Does not provide formal legal counsel or guaranteed approval outcomes. Requires external research tools for real-time verification of current fees and specific guidance dates.

    How to install

    Works the same in every agent - Claude, Cursor, Codex, Copilot and 20+ more.

    ~30 seconds
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    Verified clean 29 days ago

    • Passed all security checks, Safe to install

    Listed29 days ago

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