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- OpenClaw
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- OpenClaw
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- SKILL.md
Tencent SkillHub Β· Finance & Trading
Regulatory Affairs Head
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Provides regulatory strategy development, submission management, pathway analysis, global compliance coordination, and cross-functional team leadership.
skill openclawclawhub Free
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Provides regulatory strategy development, submission management, pathway analysis, global compliance coordination, and cross-functional team leadership.
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- ZIP package
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- Tencent SkillHub
- What's included
- SKILL.md, references/eu-mdr-submission-guide.md, references/fda-submission-guide.md, references/global-regulatory-pathways.md, references/iso-regulatory-requirements.md, scripts/regulatory_tracker.py
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Trust & source
Release facts
- Source
- Tencent SkillHub
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- Indexed source record
- Version
- 2.1.1
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- alirezarezvani
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Documentation
Head of Regulatory Affairs
Regulatory strategy development, submission management, and global market access for medical device organizations.
Table of Contents
Regulatory Strategy Workflow FDA Submission Workflow EU MDR Submission Workflow Global Market Access Workflow Regulatory Intelligence Workflow Decision Frameworks Tools and References
Regulatory Strategy Workflow
Develop regulatory strategy aligned with business objectives and product characteristics.
Workflow: New Product Regulatory Strategy
Gather product information: Intended use and indications Device classification (risk level) Technology platform Target markets and timeline Identify applicable regulations per target market: FDA (US): 21 CFR Part 820, 510(k)/PMA/De Novo EU: MDR 2017/745, Notified Body requirements Other markets: Health Canada, PMDA, NMPA, TGA Determine optimal regulatory pathway: Compare submission types (510(k) vs De Novo vs PMA) Assess predicate device availability Evaluate clinical evidence requirements Develop regulatory timeline with milestones Estimate resource requirements and budget Identify regulatory risks and mitigation strategies Obtain stakeholder alignment and approval Validation: Strategy document approved; timeline accepted; resources allocated
Regulatory Pathway Selection Matrix
Factor510(k)De NovoPMAPredicate AvailableYesNoN/ARisk LevelLow-ModerateLow-ModerateHighClinical DataUsually not requiredMay be requiredRequiredReview Time90 days (MDUFA)150 days180 daysUser Fee~$22K (2024)~$135K~$440KBest ForMe-too devicesNovel low-riskHigh-risk, novel
Regulatory Strategy Document Template
REGULATORY STRATEGY Product: [Name] Version: [X.X] Date: [Date] 1. PRODUCT OVERVIEW Intended use: [One-sentence statement of intended patient population, body site, and clinical purpose] Device classification: [Class I / II / III] Technology: [Brief description, e.g., "AI-powered wound-imaging software, SaMD"] 2. TARGET MARKETS & TIMELINE | Market | Pathway | Priority | Target Date | |--------|----------------|----------|-------------| | USA | 510(k) / PMA | 1 | Q1 20XX | | EU | Class [X] MDR | 2 | Q2 20XX | 3. REGULATORY PATHWAY RATIONALE FDA: [510(k) / De Novo / PMA] β Predicate: [K-number or "none"] EU: Class [X] via [Annex IX / X / XI] β NB: [Name or TBD] Rationale: [2β3 sentences on key factors driving pathway choice] 4. CLINICAL EVIDENCE STRATEGY Requirements: [Summarize what each market needs, e.g., "510(k): bench + usability; EU Class IIb: PMCF study"] Approach: [Literature review / Prospective study / Combination] 5. RISKS AND MITIGATION | Risk | Prob | Impact | Mitigation | |------------------------------|------|--------|-----------------------------------| | Predicate delisted by FDA | Low | High | Identify secondary predicate now | | NB audit backlog | Med | Med | Engage NB 6 months before target | 6. RESOURCE REQUIREMENTS Budget: $[Amount] Personnel: [FTEs] External: [Consultants / CRO]
FDA Submission Workflow
Prepare and submit FDA regulatory applications.
Workflow: 510(k) Submission
Confirm 510(k) pathway suitability: Predicate device identified (note K-number, e.g., K213456) Substantial equivalence (SE) argument supportable on intended use and technological characteristics No new intended use or technology concerns triggering De Novo Schedule and conduct Pre-Submission (Q-Sub) meeting if needed (see Pre-Sub Decision) Compile submission package checklist: Cover letter with device name, product code, and predicate K-number Section 1: Administrative information (applicant, contact, 510(k) type) Section 2: Device description β include photos, dimensions, materials list Section 3: Intended use and indications for use Section 4: Substantial equivalence comparison table (see example below) Section 5: Performance testing β protocols, standards cited, pass/fail results Section 6: Biocompatibility summary (ISO 10993-1 risk assessment, if patient contact) Section 7: Software documentation (IEC 62304 level, cybersecurity per FDA guidance, if applicable) Section 8: Labeling β final draft IFU, device label Section 9: Summary and conclusion Conduct internal review and quality check against FDA RTA checklist Prepare eCopy per FDA format requirements (PDF bookmarked, eCopy cover page) Submit via FDA ESG portal with user fee payment Monitor MDUFA clock and respond to AI/RTA requests within deadlines Validation: Submission accepted; MDUFA date received; tracking system updated Substantial Equivalence Comparison Example CharacteristicPredicate (K213456)Subject DeviceSame?NotesIntended useWound measurementWound measurementβIdenticalTechnology2D camera2D + AI analysisβNew TC; address belowEnergy typeNon-energizedNon-energizedβPatient contactNoNoβSE conclusionNew TC does not raise new safety/effectiveness questions; bench data demonstrates equivalent accuracy (Β±2mm vs Β±3mm predicate)
Workflow: PMA Submission
Confirm PMA pathway: Class III device or no suitable predicate Clinical data strategy defined Complete IDE clinical study if required: IDE approval Clinical protocol execution Study report completion Conduct Pre-Submission meeting Compile PMA submission checklist: Volume I: Administrative, device description, manufacturing Volume II: Nonclinical studies (bench, animal, biocompatibility) Volume III: Clinical studies (IDE protocol, data, statistical analysis) Volume IV: Labeling Volume V: Manufacturing information, sterilization Submit original PMA application Address FDA questions and deficiencies Prepare for FDA facility inspection Validation: PMA approved; approval letter received; post-approval requirements documented
FDA Submission Timeline
Milestone510(k)De NovoPMAPre-Sub MeetingDay -90Day -90Day -120SubmissionDay 0Day 0Day 0RTA ReviewDay 15Day 15Day 45Substantive ReviewDays 15β90Days 15β150Days 45β180DecisionDay 90Day 150Day 180
Common FDA Deficiencies and Prevention
CategoryCommon IssuesPreventionSubstantial EquivalenceWeak predicate comparison; no performance dataBuild SE table with data column; cite recognized standardsPerformance TestingIncomplete protocols; missing worst-case rationaleFollow FDA-recognized standards; document worst-case justificationBiocompatibilityMissing endpoints; no ISO 10993-1 risk assessmentComplete ISO 10993-1 matrix before testingSoftwareInadequate hazard analysis; no cybersecurity bill of materialsIEC 62304 compliance + FDA cybersecurity guidance checklistLabelingInconsistent claims vs. IFU; missing symbols standardCross-check label against IFU; cite ISO 15223-1 for symbols See: references/fda-submission-guide.md
EU MDR Submission Workflow
Achieve CE marking under EU MDR 2017/745.
Workflow: MDR Technical Documentation
Confirm device classification per MDR Annex VIII Select conformity assessment route based on class: Class I: Self-declaration Class IIa/IIb: Notified Body involvement Class III: Full NB assessment Select and engage Notified Body (for Class IIa+) β see selection criteria below Compile Technical Documentation per Annex II checklist: Annex II Β§1: Device description, intended purpose, UDI Annex II Β§2: Design and manufacturing information (drawings, BoM, process flows) Annex II Β§3: GSPR checklist β each requirement mapped to evidence (standard, test report, or justification) Annex II Β§4: Benefit-risk analysis and risk management file (ISO 14971) Annex II Β§5: Product verification and validation (test reports) Annex II Β§6: Post-market surveillance plan Annex XIV: Clinical evaluation report (CER) β literature, clinical data, equivalence justification Establish and document QMS per ISO 13485 Submit application to Notified Body Address NB questions and coordinate audit Validation: CE certificate issued; Declaration of Conformity signed; EUDAMED registration complete GSPR Checklist Row Example GSPR RefRequirementStandard / GuidanceEvidence DocumentStatusAnnex I Β§1Safe design and manufactureISO 14971:2019Risk Management File v2.1CompleteAnnex I Β§11.1Devices with measuring function Β±accuracyEN ISO 15223-1Performance Test Report PT-003CompleteAnnex I Β§17CybersecurityMDCG 2019-16Cybersecurity Assessment CS-001In progress
Clinical Evidence Requirements by Class
ClassClinical RequirementDocumentationIClinical evaluation (CE)CE reportIIaCE with literature focusCE report + PMCF planIIbCE with clinical dataCE report + PMCF + clinical study (some)IIICE with clinical investigationCE report + PMCF + clinical investigation
Notified Body Selection Criteria
Scope: Designated for your specific device category Capacity: Confirmed availability within target timeline Experience: Track record with your technology type Geography: Proximity for on-site audits Cost: Fee structure transparency Communication: Responsiveness and query turnaround See: references/eu-mdr-submission-guide.md
Global Market Access Workflow
Coordinate regulatory approvals across international markets.
Workflow: Multi-Market Submission Strategy
Define target markets based on business priorities Sequence markets for efficient evidence leverage: Phase 1: FDA + EU (reference markets) Phase 2: Recognition markets (Canada, Australia) Phase 3: Major markets (Japan, China) Phase 4: Emerging markets Identify local requirements per market: Clinical data acceptability Local agent/representative needs Language and labeling requirements Develop master technical file with localization plan Establish in-country regulatory support Execute parallel or sequential submissions Track approvals and coordinate launches Validation: All target market approvals obtained; registration database updated
Market Priority Matrix
MarketSizeComplexityRecognitionPriorityUSALargeHighN/A1EULargeHighN/A1β2CanadaMediumMediumMDSAP2AustraliaMediumLowEU accepted2JapanLargeHighLocal clinical3ChinaLargeVery HighLocal testing3BrazilMediumHighGMP inspection3β4
Documentation Efficiency Strategy
Document TypeSingle SourceLocalization RequiredTechnical file coreYesFormat adaptationRisk managementYesNoneClinical dataYesBridging assessmentQMS certificateYes (ISO 13485)Market-specific auditLabelingMaster labelTranslation, local requirementsIFUMaster contentTranslation, local symbols See: references/global-regulatory-pathways.md
Regulatory Intelligence Workflow
Monitor and respond to regulatory changes affecting product portfolio.
Workflow: Regulatory Change Management
Monitor regulatory sources: FDA Federal Register, guidance documents EU Official Journal, MDCG guidance Notified Body communications Industry associations (AdvaMed, MedTech Europe) Assess relevance to product portfolio Evaluate impact: Timeline to compliance Resource requirements Product changes needed Develop compliance action plan Communicate to affected stakeholders Implement required changes Document compliance status Validation: Compliance action plan approved; changes implemented on schedule
Regulatory Monitoring Sources
SourceTypeFrequencyFDA Federal RegisterRegulations, guidanceDailyFDA Device Database510(k), PMA, recallsWeeklyEU Official JournalMDR/IVDR updatesWeeklyMDCG GuidanceEU implementationAs publishedISO/IECStandards updatesQuarterlyNotified BodyAudit findings, trendsPer interaction
Impact Assessment Template
REGULATORY CHANGE IMPACT ASSESSMENT Change: [Description] Source: [Regulation/Guidance] Effective Date: [Date] Assessment Date: [Date] Assessed By: [Name] AFFECTED PRODUCTS | Product | Impact (H/M/L) | Action Required | Due Date | |---------|----------------|------------------------|----------| | [Name] | [H/M/L] | [Specific action] | [Date] | COMPLIANCE ACTIONS 1. [Action] β Owner: [Name] β Due: [Date] 2. [Action] β Owner: [Name] β Due: [Date] RESOURCE REQUIREMENTS: Budget $[X] | Personnel [X] hrs APPROVAL: Regulatory _____________ Date _______ / Management _____________ Date _______
Pathway Selection and Classification Reference
FDA Pathway Selection Is predicate device available? β Yesββ΄βNo β β βΌ βΌ Is device Is risk level substantially Low-Moderate? equivalent? β β Yesββ΄βNo Yesββ΄βNo β β β β βΌ βΌ βΌ βΌ De Novo PMA 510(k) Consider required De Novo or PMA EU MDR Classification Is the device active? β Yesββ΄βNo β β βΌ βΌ Is it an Does it contact implant? the body? β β Yesββ΄βNo Yesββ΄βNo β β β β βΌ βΌ βΌ βΌ III IIb Check Class I contact (measuring/ type sterile if and applicable) duration
Pre-Submission Meeting Decision
FactorSchedule Pre-SubSkip Pre-SubNovel TechnologyβNew Intended UseβComplex TestingβUncertain PredicateβClinical Data NeededβWell-establishedβClear PredicateβStandard Testingβ
Regulatory Escalation Criteria
SituationEscalation LevelActionSubmission rejectionVP RegulatoryRoot cause analysis, strategy revisionMajor deficiencyDirectorCross-functional response teamTimeline at riskManagementResource reallocation reviewRegulatory changeVP RegulatoryPortfolio impact assessmentSafety signalExecutiveImmediate containment and reporting
Scripts
ToolPurposeUsageregulatory_tracker.pyTrack submission status and timelinespython regulatory_tracker.py Regulatory Tracker Features: Track multiple submissions across markets Monitor status and target dates Identify overdue submissions Generate status reports Example usage: $ python regulatory_tracker.py --report status Submission Status Report β 2024-11-01 ββββββββββββββββββββ¬βββββββββββ¬βββββββββββββ¬ββββββββββββββ¬βββββββββββ β Product β Market β Type β Target Date β Status β ββββββββββββββββββββΌβββββββββββΌβββββββββββββΌββββββββββββββΌβββββββββββ€ β WoundScan Pro β USA β 510(k) β 2024-12-01 β On Track β β WoundScan Pro β EU β MDR IIb β 2025-03-01 β At Risk β β CardioMonitor X1 β Canada β Class II β 2025-01-15 β On Track β ββββββββββββββββββββ΄βββββββββββ΄βββββββββββββ΄ββββββββββββββ΄βββββββββββ 1 submission at risk: WoundScan Pro EU β NB engagement not confirmed.
References
DocumentContentfda-submission-guide.mdFDA pathways, requirements, review processeu-mdr-submission-guide.mdMDR classification, technical documentation, clinical evidenceglobal-regulatory-pathways.mdCanada, Japan, China, Australia, Brazil requirementsiso-regulatory-requirements.mdISO 13485, 14971, 10993, IEC 62304, 62366 requirements
Key Performance Indicators
KPITargetCalculationFirst-time approval rate>85%(Approved without major deficiency / Total submitted) Γ 100On-time submission>90%(Submitted by target date / Total submissions) Γ 100Review cycle compliance>95%(Responses within deadline / Total requests) Γ 100Regulatory hold time<20%(Days on hold / Total review days) Γ 100
Related Skills
SkillIntegration Pointmdr-745-specialistDetailed EU MDR technical requirementsfda-consultant-specialistFDA submission deep expertisequality-manager-qms-iso13485QMS for regulatory compliancerisk-management-specialistISO 14971 risk management
Category context
Trading, swaps, payments, treasury, liquidity, and crypto-financial operations.
Source: Tencent SkillHub
Largest current source with strong distribution and engagement signals.
Package contents
Included in package
5 Docs1 Scripts
- SKILL.md
- references/eu-mdr-submission-guide.md
- references/fda-submission-guide.md
- references/global-regulatory-pathways.md
- references/iso-regulatory-requirements.md
- scripts/regulatory_tracker.py