Gesundheits- und Krankenpfleger

ISO 13485 Certification Documentation Assistant

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

Sicherheit

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。

Fantasia19990

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Rechtsanwälte

Compliance-Beauftragte

Ehe- und Familientherapeuten

Hausärzte

Pflegehelfer

Psychologische Berater

Apotheker

Medizinische Dokumentationsassistenten

Fachkräfte für medizinische Dokumentation

Detektive und Kriminalermittler

Diätassistenten und Ernährungsberater

Gesundheitsberater

Sozialarbeiter für psychische Gesundheit und Suchtberatung

Nurse Practitioners

Sozialarbeiter für Kinder, Familien und Schulen

Bio- und Biomedizintechniker

Sportphysiologen

Zahnärzte

Medizinische Fachangestellte

Tierärzte

Internisten

Sicherheitsingenieure

Medizinische Sozialarbeiter

Schlichter und Mediatoren

Sicherheitsmitarbeiter

Physiotherapeuten

Leitstellenmitarbeiter

Rehabilitationsberater

Feuerwehrleute

Ergotherapie-Assistenten

Physiotherapie-Assistenten

Radiologieassistenten

Dermatologen

Richter und Amtsrichter

Genetik-Berater

Neurologen

Hebammen

Fachkräfte für Arbeitssicherheit

Brandschutzinspektoren

Alltagsbegleiter

Sozialassistenten

Infanterieoffiziere

Sucht- und Verhaltensberater

Ernährungsberater-Assistenten

Massagetherapeuten

Bestatter

Notruf-Disponenten

Notfallsanitäter

Waldbrandinspektoren

Psychiatrische Pflegehelfer

Arztassistenten

Offiziere der Spezialkräfte

Logopäden

Sporttrainer

Rettungssanitäter

Pharmazeutische Assistenten

Rettungsschwimmer und Pistenretter

Rechtsanwälte

Compliance-Beauftragte

Ehe- und Familientherapeuten

Hausärzte

Pflegehelfer

Psychologische Berater

Apotheker

Medizinische Dokumentationsassistenten

Fachkräfte für medizinische Dokumentation

Detektive und Kriminalermittler

Diätassistenten und Ernährungsberater

Gesundheitsberater

Sozialarbeiter für psychische Gesundheit und Suchtberatung

Nurse Practitioners

Sozialarbeiter für Kinder, Familien und Schulen

Bio- und Biomedizintechniker

Sportphysiologen

Zahnärzte

Medizinische Fachangestellte

Tierärzte

Internisten

Sicherheitsingenieure

Medizinische Sozialarbeiter

Schlichter und Mediatoren

Sicherheitsmitarbeiter

Physiotherapeuten

Leitstellenmitarbeiter

Rehabilitationsberater

Feuerwehrleute

Ergotherapie-Assistenten

Physiotherapie-Assistenten

Radiologieassistenten

Dermatologen

Richter und Amtsrichter

Genetik-Berater

Neurologen

Hebammen

Fachkräfte für Arbeitssicherheit

Brandschutzinspektoren

Alltagsbegleiter

Sozialassistenten

Infanterieoffiziere

Sucht- und Verhaltensberater

Ernährungsberater-Assistenten

Massagetherapeuten

Bestatter

Notruf-Disponenten

Notfallsanitäter

Waldbrandinspektoren

Psychiatrische Pflegehelfer

Arztassistenten

Offiziere der Spezialkräfte

Logopäden

Sporttrainer

Rettungssanitäter

Pharmazeutische Assistenten

Rettungsschwimmer und Pistenretter

Finanzen & Investitionen

Risk Management Specialist

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

thiagofernandes1987-create1

Gesundheit & Fitness

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

Akademisch

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

thiagofernandes1987-create1

Capa Officer

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

Immobilien & Recht

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

thiagofernandes1987-create1

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

Wellness & Gesundheit

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。

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

ISO 13485 Certification Documentation Assistant

Yezez90

Gesundheit & Fitness

Test Report Analysis

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

severi0

Mdr 745 Specialist

neekware0

Architekturmuster

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

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

Finanzen & Investitionen

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

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

Head of Regulatory Affairs

neekware0

Wellness & Gesundheit

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