Alterra AI installs operational AI where medical device SMBs bleed time and cash — CAPA, complaints, 510(k) prep, supplier files. No new platform. Every action logged for FDA CP 7382.850 and ISO 13485:2016.
Ranges reflect Alterra AI project estimates modeled on public benchmarks (FDA Form 483 data 2023–2026, FDA Group, MedDeviceGuide, RAPS). Individual results vary by baseline maturity.
FDA's Quality Management System Regulation took effect February 2, 2026 — no transition period. Meanwhile, CAPA (12.4%), design controls (12.3%), and complaint handling (10.6%) account for over one-third of all Form 483 observations. If a diligence team runs those searches on your company, the answers had better be clean.
Open CAPAs past 90 days signal weak investigation ownership and are the first thing an acquirer's quality diligence lead asks about. Manual root-cause analysis is where the days disappear.
Predicate rationales, testing summaries, labeling, and cybersecurity docs get re-authored for every submission. FY2026 user fee is $26,067 — but internal prep cost of $30K–$500K is where the real bleed lives.
FDA Compliance Program 7382.850 explicitly lists supplier audit reports as inspectable. "Verbal check-ins" and emailed summaries are now Form 483 exposure. Most SMBs cannot produce a complete supplier file on 30 minutes' notice.
Each solution is a discrete, scoped engagement with a fixed timeline and named KPI targets. Deploy one, deploy all four. No platform lock-in.
Bring your quality management system into ISO 13485:2016 + QMSR alignment. AI-drafted procedures, mapped risk records, ready-for-inspection evidence packages under CP 7382.850.
AI-assisted intake, root-cause analysis, and effectiveness verification for CAPA — with automatic trend detection across complaints, nonconformances, and MDR-eligible events.
510(k), Technical File, and change-assessment drafting from your DHF, protocols, and predicate library. Pre-sub package assembly with cybersecurity, SBOM, and PCCP-aware sections.
Supplier scorecards, SCAR management, and complete audit-ready supplier files — with continuous monitoring for FDA warning letters, recalls, and certification lapses affecting your ASL.
Every dollar of enterprise value in a growing medtech is priced against quality risk. These are the metrics that show up in QoR, buyer due diligence, and QMSR inspection outcomes.
The single most-asked question in quality diligence. Buyers want a downward trend they can point to at the closing table.
High conversion rates mean the trend engine works. Zero conversion means no one is looking.
Late 510(k) submissions delay revenue. Clean, well-organized packages accelerate FDA review cycles.
Trended supplier quality data is the fastest way to prove ASL discipline to an acquirer.
Alterra AI's medtech engagement layers on top of your existing QMS — Greenlight Guru, MasterControl, Qualio, Veeva, or spreadsheet-based systems. You keep your platform. You get the operational improvement.
Read-only review of your QMS, CAPA log, complaint log, top-3 supplier files, and last inspection outcome. Prioritized findings ranked by risk and time-to-value.
Fixed-fee, fixed-timeline proposal on one to four business cases. Named KPI targets, sign-off deliverables, and validation plan.
AI workflows deployed inside your existing QMS and CRM. Every action logged, versioned, and mapped to a controlled process step. IQ/OQ artifacts included.
Live in 3–6 weeks. You own everything. Optional 90-day KPI monitoring package with monthly investor-ready metric packs.
FDA does not prohibit AI-assisted authoring. What matters is that the record was created inside a controlled process with human review, version control, and an auditable trail. Alterra AI treats every AI action as a controlled process step — logged, attributable, and reviewable — so evidence stands up to FDA CP 7382.850 inspections and Notified Body audits.
No. We deploy on top of Greenlight Guru, MasterControl, Qualio, Veeva, ETQ, or your spreadsheet-based system. If you're mid-migration, we'll align the build to your target platform.
ISO 13485:2016 is now incorporated by reference into 21 CFR Part 820 under the QMSR. Our deployment uses ISO 13485 clause structure as the design baseline, so the same evidence supports MDR Technical Files and Notified Body audits without a parallel build.
Common for our clients. Pre-clearance companies benefit most from the QMS/QMSR and Regulatory Submissions business cases — building a QMS designed to survive its first inspection instead of one retrofit under pressure.
We ship working systems in 3–6 weeks with fixed-fee scope. Big firms deliver strategy decks and staff-augmentation retainers. Both have a place — ours is faster and closer to the operating floor.
You do. Everything is built in your instance of your systems. No Alterra platform, no ongoing license fees. Optional monitoring is a separate, cancelable service.
One conversation. A read-only review of your QMS, CAPA log, and last inspection outcome. A prioritized punch list ranked by risk and time-to-value. No obligation.
Book the 48-hour Assessment