Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.

strmt70

安全

Qms Audit Expert

针对医疗器械 QMS 的 ISO 13485 内部审计专业知识。涵盖审计规划、执行、不符合项分类和 CAPA 验证。适用于内部审计规划、审计执行、发现项分类、外部审计准备或审计方案管理。

Risk Management Specialist

"Use — Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk"

thiagofernandes1987-create1

健康与健身

Only Baby Skills

Analyze contraction JSON and baby log JSON to assess mum's labour/contraction situation and baby's feeding and diaper status. Use when the user provides (or references) contractions_*.json and babyLogs_*.json files and wants to know if mum is safe and baby is healthy, or asks for a summary of contractions, feeding, or diaper changes.

duclm1x11

学术

Mnemonic Researcher

CRITICAL AUTOMATION: Automatically researches PROVEN medical mnemonics during study guide creation. ACTIVATES when creating study guides and mnemonics are mentioned. Launches the medical-mnemonic-researcher agent to find established USMLE mnemonics from medical education sources. NEVER invents mnemonics - only finds ones that already exist and are validated by medical students.

dung-nguyen31

实验室工具

Capa Officer

"Use — CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness"

thiagofernandes1987-create1

房产与法律

Network Adequacy Analysis

Assess provider network adequacy against CMS, state, and NCQA standards for time-distance, provider-to-member ratios, appointment wait times, and essential community provider requirements to ensure regulatory compliance and member access.

GoldenZero1

销售与营销

Senior FDA Consultant and Specialist

Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.

Mishit181

健康养生

Tcm Constitution Analyzer

Use — 分析中医体质数据、识别体质类型、评估体质特征,并提供个性化养生建议。支持与营养、运动、睡眠等健康数据的关联分析。

thiagofernandes1987-create1

实验室工具

Mdr 745 Specialist

EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration.

Tonybleything760

实验室工具

ISO 13485 Certification Documentation Assistant

Yezez90

健康与健身

Test Report Analysis

Extracts and stores physiological data from test reports (lactate tests, VO2max, metabolic panels, medical assessments)

severi0

实验室工具

Mdr 745 Specialist

neekware0

架构模式

U01484 Constraint Compilation For Healthcare Operations

Build and operate the "Constraint Compilation for healthcare operations" capability for healthcare operations. Use when this exact capability is required by autonomous or human-guided missions.

zwright80

销售与营销

Head of Regulatory Affairs

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.

desenyon0

金融与投资

Risk Management Specialist

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.

zhangzhang-111-i0

销售与营销

Mortuarytasksai

Access 127+ AI-powered skills for mortuary science professionals and funeral home staff. Use when: user asks about death certificates, cremation authorization, embalming documentation, preneed planning, funeral licensing, case management, family notifications, or any mortuary or funeral home administration task.

laudoluxDev0

销售与营销

Head of Regulatory Affairs

neekware0

健康养生

Tcm Constitution Analyzer

分析中医体质数据、识别体质类型、评估体质特征,并提供个性化养生建议。支持与营养、运动、睡眠等健康数据的关联分析。

lactuphong0

实验室工具

ISO 13485 Certification Documentation Assistant

huamu6680

健康养生

Tcm Fa Zheng Dui Ying

中医"法证对应"临床思维辅助。当用户讨论中医辨证论治、方剂分析、病机拆解、治法确立、药物选择、或询问如何从"方证对应"进阶到"法证对应"时使用。适用于：分析复杂病机、拆解证候要素、确立治疗法则、灵活选药组方、理解"法不变而药可变"的原则、横向对比同类药物异同、纵向理解药物多重作用等场景。

GeorgeDoors8880

房产与法律

Care Compliance Checker

Checks care service operations against CQC regulatory standards, safeguarding requirements, and sector-specific compliance frameworks. Reviews care plans, incident reports, staffing records, and operational procedures for regulatory alignment and identifies gaps requiring remediation.

garethdaine0

注册护士

注册护士

Risk Management Specialist

iso-13485-certification

ISO 13485 Certification Documentation Assistant

Qms Audit Expert

Risk Management Specialist

Only Baby Skills

Mnemonic Researcher

Capa Officer

Network Adequacy Analysis

Senior FDA Consultant and Specialist

Tcm Constitution Analyzer

Mdr 745 Specialist

ISO 13485 Certification Documentation Assistant

Test Report Analysis

Mdr 745 Specialist

U01484 Constraint Compilation For Healthcare Operations

Head of Regulatory Affairs

Risk Management Specialist

Mortuarytasksai

Head of Regulatory Affairs

Tcm Constitution Analyzer

ISO 13485 Certification Documentation Assistant

Tcm Fa Zheng Dui Ying

Care Compliance Checker