The Compliance & Quality Stack

Claude skills for compliance and quality teams cover the overlapping regulatory frameworks that medical device and digital health companies must satisfy simultaneously. This stack was built for teams navigating FDA submissions, EU MDR approvals, ISO 13485 certification, and GDPR compliance — often all at once.

What these skills do

Regulatory Affairs Head

Strategic oversight of the regulatory program — submission planning, agency interaction strategy, and the prioritization decisions that determine which markets you enter and when. Covers both FDA (510(k), PMA, De Novo) and EU MDR pathways.

Quality Manager — QMS ISO 13485

Build and maintain a quality management system to ISO 13485 standard. Covers document control, process validation, supplier management, and the audit-readiness requirements that certification bodies actually check.

Quality Manager — QMR

Prepare quality management reviews with the right data, trend analysis, and decision outputs. Covers the structured review format that ISO 13485 requires and the common gaps that auditors flag.

CAPA Officer

Run corrective and preventive action processes systematically — root cause analysis, action planning, effectiveness verification, and the documentation trail that survives an audit. Covers both internal CAPAs and those triggered by customer complaints or NCRs.

Risk Management Specialist

Apply ISO 14971 risk management methodology to medical devices — hazard identification, severity and probability estimation, risk control measures, and residual risk documentation. Produces the risk management file that regulators expect.

FDA Consultant

Navigate FDA regulatory requirements for medical devices and software — 510(k) preparation, predicate device strategy, substantial equivalence argumentation, and the submission formats that reviewers expect.

MDR Specialist

Prepare EU MDR technical documentation, clinical evaluation reports, and PMCF plans. Covers the Article 10 obligations, Annex requirements, and the notified body expectations that differ from previous MDD requirements.

GDPR Expert

Assess data processing activities, draft privacy notices and DPAs, run DPIAs, and document the lawful basis for processing. Covers the specific requirements for health data under Article 9.

Information Security Manager — ISO 27001

Design and document an information security management system to ISO 27001 standard. Covers the Annex A controls, Statement of Applicability, and the risk assessment methodology that certification audits require.

Quality Documentation Manager

Maintain controlled documents — SOPs, work instructions, forms, and records — with the version control and review cycles that QMS standards require. Covers document hierarchy and the common documentation gaps found in audits.

QMS Audit Expert & ISMS Audit Expert

Prepare for and conduct internal audits of quality management and information security systems. Covers audit planning, evidence gathering, nonconformity classification, and audit report writing.

Who this is for

• MedTech and digital health companies seeking FDA clearance or EU MDR approval
• Regulatory affairs and quality management professionals in regulated industries
• Software companies building products that fall under medical device classification
• Compliance teams managing simultaneous ISO 13485, ISO 27001, and GDPR obligations

For more on the research and regulated-industry audience, see the researchers audience page. If your primary concern is information security rather than QMS, see the Security Engineering Stack.