Regulatory & Quality skills.
17 skills in Regulatory & Quality. Find one, read the SKILL.md, install it.
17 skills in Regulatory & Quality
- Regulatory & Quality
Agent decision receipts
Helps when an autonomous agent takes a consequential, side-effecting action (deploy, delete, pay, grant-access, model decision) that may need proof...
CommunityFreev1.0.0 - Regulatory & Quality
CAPA officer
Helps with running CAPA investigations, 5-Why or fishbone root cause analysis, corrective action planning and tracking, effectiveness verification...
CommunityFreev1.0.0 - Regulatory & Quality
EU AI act specialist
Helps with classifying an AI system's EU AI Act risk tier, planning Article 43 conformity assessment for a high-risk system, or scoping...
CommunityFreev1.0.0 - Regulatory & Quality
FDA consultant specialist
Helps with handling FDA submission pathway selection (510(k)/PMA/De Novo), QMSR/ISO 13485 compliance, medical device HIPAA assessments, or device...
CommunityFreev1.0.0 - Regulatory & Quality
GDPR DSGVO expert
Helps with running GDPR/DSGVO compliance assessments, privacy audits, DPIA generation, or data subject rights (DSAR) tracking, e.g. checking GDPR...
CommunityFreev1.0.0 - Regulatory & Quality
Information security manager ISO 27001
Helps with designing an ISMS, running a security risk assessment, implementing ISO 27001/27002 controls, preparing for certification or a security...
CommunityFreev1.0.0 - Regulatory & Quality
ISMS audit expert
Helps with planning or running an ISO 27001 ISMS audit — Annex A control assessment, Statement of Applicability, gap analysis, nonconformity...
CommunityFreev1.0.0 - Regulatory & Quality
ISO 42001 specialist
Helps with scoring AIMS gaps against ISO 42001 Clauses 4-10, building an AI risk register with Annex A control mapping, or planning a Clause 9.2...
CommunityFreev1.0.0 - Regulatory & Quality
MDR 745 specialist
Helps with classifying a medical device under EU MDR, building or gap-checking a technical file, planning clinical evaluation or PMS/PSUR cadence, or...
CommunityFreev1.0.0 - Regulatory & Quality
QMS audit expert
Helps with planning internal audits, executing ISO 13485 QMS audits, classifying findings, preparing for external audits, or managing an audit...
CommunityFreev1.0.0 - Regulatory & Quality
Quality documentation manager
Helps with working on document control procedures, change control workflows, document numbering, version management, electronic signature compliance...
CommunityFreev1.0.0 - Regulatory & Quality
Quality manager QMR
Helps with leading management reviews, setting quality policy and objectives, monitoring quality KPIs and cost of quality, or exercising QMR...
CommunityFreev1.0.0 - Regulatory & Quality
Quality manager QMS ISO 13485
Helps with working with medical device quality systems: preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up...
CommunityFreev1.0.0 - Regulatory & Quality
RA QM skills
Helps when a HealthTech/MedTech compliance request doesn't obviously match one domain and you need to route it to the right regulatory or...
CommunityFreev1.0.0 - Regulatory & Quality
Regulatory affairs head
Helps with planning or executing FDA 510(k)/De Novo/PMA submissions, achieving CE marking under EU MDR, preparing pre-submission materials, or...
CommunityFreev1.0.0 - Regulatory & Quality
Risk management specialist
Use when the user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix...
CommunityFreev1.0.0 - Regulatory & Quality
SOC 2 compliance
Helps you prepare for SOC 2 audits, map Trust Service Criteria, build control matrices, collect audit evidence, perform gap analysis, or assess Type...
CommunityFreev1.0.0
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