FDA
FDA 513(g) Request for Information Review
Expert review of your 513(g) response before submission — ensuring your device classification rationale is accurate and complete.
FDA
FDA Pre-Submission (Q-Sub) Meeting Package Review
Strengthen your Q-Sub package before FDA engagement — including question framing, supporting data review, and strategy alignment.
Quality & QMS
Corrective and Preventive Action (CAPA) System Review
Identify gaps in your CAPA process before an FDA inspection finds them — with actionable remediation recommendations.
Quality & QMS
Device History Record (DHR) Review
Verify your DHR is complete, accurate, and inspection-ready — covering lot records, manufacturing steps, and release criteria.
Quality & QMS
ISO 13485 QMS Implementation Review
Evaluate your QMS implementation against ISO 13485 requirements — with detailed findings and prioritized corrective actions.
Quality & QMS
FDA QSR / ISO 13485 Gap Assessment
Side-by-side assessment of your quality system against both FDA QMSR and ISO 13485 — identifying compliance gaps and remediation priorities.
FDA
FDA Premarket Notification 510(k) Review
Comprehensive review of your 510(k) submission — predicate selection, substantial equivalence argument, performance testing, and labeling.
EU MDR
EU MDR Technical File Review
In-depth review of your EU MDR Technical File — clinical evaluation, risk management, GSPR checklist, and notified body readiness.
FDA
Design History File (DHF) Review
Review your DHF for completeness and traceability — design inputs, outputs, verification, validation, and design transfer documentation.
FDA
FDA De Novo Classification Request Review
Review your De Novo request for novel device classification — including special controls rationale, risk assessment, and benefit-risk summary.
Quality & QMS
Conduct Internal Quality Audit
On-site or remote audit of your quality system by a former FDA investigator — findings report, observation log, and corrective action plan included.
FDA
FDA Premarket Approval (PMA) Application Review
Full review of your Class III PMA application — clinical data, manufacturing section, risk analysis, labeling, and submission strategy from a former FDA insider.