Quality System & Compliance
The Quality Management System Regulation took effect February 2, 2026, incorporating ISO 13485:2016 by reference and replacing the prior QSR structure. FDA also retired its QSIT inspection model the same day. Quality systems and audit checklists built entirely around the old framework may not map cleanly onto this structure without a genuine gap assessment.
- QMSR (21 CFR Part 820) gap assessment
The Quality Management System Regulation took effect February 2, 2026, replacing the former Quality System Regulation and incorporating ISO 13485:2016 by reference. FDA also retired its old QSIT inspection approach in favor of the updated compliance program (7382.850) on the same date. Quality systems built around the old QSR structure, or documentation that hasn't been mapped to ISO 13485's clause structure, may now have real gaps. We assess your system against the current regulation and identify what needs to change.
- Design controls review and documentation support
Design control documentation is scrutinized closely in both premarket review and post-market inspection. We review your design history file for the traceability and completeness FDA and auditors expect to see.
- Establishment registration and device listing
Registration and listing are procedural but unforgiving of errors, incorrect classification or listing information creates downstream problems. We manage the process under 21 CFR Part 807 to keep your registration accurate and current.
- UDI system compliance review
UDI requirements touch labeling, the GUDID database, and your quality system simultaneously. We review your UDI implementation against current compliance dates and data requirements.
- Post-market surveillance plan development
A surveillance plan built only to satisfy a checklist rarely catches what actually matters once a device is on the market. We build plans structured around your device's actual risk profile and the signals worth monitoring.
- Post-approval study (PAS) design for PMA holders
PAS commitments are enforceable conditions of approval, not optional follow-up work. We help design studies that satisfy FDA's post-approval requirements without over-committing to burden you can't sustain.
- MDR advisory and reportability determinations
Reportability decisions carry real regulatory risk in both directions, over-reporting and under-reporting each create their own problems. We help you make and document defensible reportability determinations under 21 CFR Part 803.