Services
Choose targeted support or end-to-end delivery. We keep it clear, audit-ready, and practical.
ISO 13485 QMS setup
QMS structure, SOPs, records, and training aligned to your device and stage.
Internal audits
Audit plans, execution, reporting, and follow-up actions to reduce findings.
CAPA & remediation
Root cause, CAPA design, effectiveness checks, and documentation support.
FDA submission support
Submission planning, technical writing, and review packages for common pathways.
Design controls
DHFs, traceability, risk management integration, and design review support.
Supplier controls
Supplier qualification, agreements, monitoring, and evidence packages.
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