Align your quality management system to ISO 13485:2016 and 21 CFR Part 820 (QMSR) — with AI-drafted procedures, mapped risk records, and inspection-ready evidence under FDA CP 7382.850. Deployed inside your existing QMS in 3–6 weeks.
QMSR took effect February 2, 2026 with no transition period. Class II SMBs still running the legacy QSR structure — or a hybrid — face two costs: remediation under pressure and diligence exposure with any investor or acquirer. Alterra AI installs an AI layer on top of your existing QMS to compress remediation from 6+ months to under 6 weeks, then leaves you with a defensible evidence trail.
ISO 13485:2016 is now incorporated by reference into 21 CFR Part 820. The regulation looks familiar on paper — but the inspection model changed. FDA's new Compliance Program 7382.850 signals a more evidence-driven, risk-based approach. For Class II SMBs with growing product portfolios, three specific gaps are showing up:
Four AI workflows deployed inside your existing QMS platform — Greenlight Guru, MasterControl, Qualio, Veeva, ETQ, or spreadsheet-based:
Ingests your current procedures, maps them clause-by-clause to ISO 13485:2016 + QMSR, and generates a prioritized remediation list ranked by inspection risk.
Drafts revised procedures with clause references, risk-integration language, and change-control artifacts. Every draft is a controlled record with human sign-off gates.
Single searchable index across QMS records, DHF, DMR, DHR, supplier files, and training logs. Inspector-facing view + internal QA view.
Auto-generated matrix showing who is qualified against which procedures, with time-stamped evidence and gap alerts before assignment lapses expire.
| Metric | Before (typical) | After (target) | Source of estimate |
|---|---|---|---|
| QMSR gap remediation time | 4–8 months | 4–8 weeks | Alterra AI project estimate |
| Procedure drafting effort | 20–40 hrs per SOP | 4–8 hrs per SOP | Alterra AI project estimate |
| Time to produce inspection package | 3–5 days | < 2 hours | Alterra AI project estimate |
| Training gap detection lag | Quarterly / reactive | Real-time alerts | Alterra AI project estimate |
| Procedure-to-clause traceability | Manual, partial | 100%, auto-maintained | Alterra AI project estimate |
Ranges based on public benchmarks and modeled internally; individual results depend on baseline QMS maturity, product portfolio size, and inspection history.
What a diligence team will ask: "Show me your procedure-to-clause mapping under QMSR. Show me the training matrix. Show me your last inspection." An AI-built evidence index answers all three in the same click. That is what "audit-ready" now means in practice — and it moves quality risk from a discount factor to a neutral or positive signal.
Every AI action inside the Alterra deployment is a controlled process step. The output is versioned, attributable to a reviewer, and traceable to source records. FDA's CP 7382.850 shift toward record-driven review is aligned with, not opposed to, evidence assembled this way. The same evidence supports EU MDR Technical Files and Notified Body audits — no parallel build.
Class II SMB, 15–500 employees, growing product portfolio, preparing for Series B/C or acquisition inside 24 months, one FDA inspection or fewer in the last 3 years, QMS on any modern platform or well-organized spreadsheets.
Pre-clinical only with no QMS scaffolding, Class III with active PMA under submission (different engagement model), or actively under Warning Letter — those need CAPA-first engagements before QMS structural work.
Read-only assessment. Prioritized punch list ranked by inspection risk and time-to-value. Fixed-fee proposal within 5 business days.
Book the 48-hour Assessment