Compliance

Manage Corrective and Preventive Actions — root cause analysis, CAPA documentation, effectiveness verification, and closing the quality loop per ISO standards.

Navigate FDA regulatory pathways — 510(k), PMA, De Novo, and QSR 21 CFR Part 820 compliance for medical device manufacturers and digital health companies.

Navigate EU GDPR and German DSGVO compliance — data processing agreements, DPIAs, privacy policies, consent management, and data subject rights workflows.

Implement and manage an ISMS per ISO 27001/27002 — risk assessments, security controls, incident management, and certification readiness.

Conduct ISO 27001 internal audits — audit planning, evidence collection, nonconformance identification, and management review preparation.

EU Medical Device Regulation compliance — device classification, UDI registration, EUDAMED submission, and technical file documentation under MDR 2017/745.

Conduct ISO 13485 internal quality management system audits — audit planning, process evaluation, nonconformance reports, and certification support.

Manage regulatory documentation and document control systems — SOPs, work instructions, technical files, and version-controlled document management per ISO standards.

Quality Management Representative accountability — QMS governance, management review facilitation, compliance dashboards, and overall quality system ownership.

Implement and maintain ISO 13485 quality management systems for medical devices — gap analysis, process design, procedure writing, and certification readiness.

Lead regulatory strategy for medical devices — FDA submissions, EU MDR market access, regulatory pathway selection, and global market entry planning.

Implement ISO 14971 risk management for medical devices — FMEA, fault tree analysis, benefit-risk assessments, and risk management file maintenance.