Audits & Inspections
ISO 13485 Audits
We support organizations with internal and supplier audits aligned to ISO 13485 requirements, helping identify gaps, strengthen compliance, and prepare for certification or surveillance audits. Our audits focus on practical findings and risk-based improvement, not checklist compliance.
Certification Readiness & Mock Audits
We conduct mock and readiness audits to assess quality system maturity and compliance ahead of certification or surveillance audits. Our audits simulate real audit conditions and provide clear, actionable findings to reduce risk and support a successful audit outcome.
MDSAP Audit Support & Readiness
We support organizations preparing for MDSAP audits, including readiness assessments, gap remediation, and audit support. Our approach focuses on understanding MDSAP expectations across participating regulatory authorities and strengthening system-level compliance.
FDA Inspection Readiness (21 CFR 820 / QMSR)
We help organizations prepare for FDA inspections by assessing compliance with 21 CFR 820 / QMSR requirements, identifying inspection risks, and supporting inspection readiness activities. Our focus is on ensuring systems, records, and teams are prepared for FDA scrutiny.