← all vendors
QT9 ERP
AI score: 87 / 100
Exceptional for SMB
ERP + QMS purpose-built for FDA-regulated manufacturers
Type: plug-ins / best-of-breed, growing (ops / MRP) · Tech: modern · Budget: SMB friendly ($10k–$70k/yr)
Core verticals: aerospace / defense, medical / bioscience
Functions: sales / CRM, purchasing, quality, reporting / BI
One of the cleanest options for medical device and regulated manufacturers. Handles 21 CFR Part 11, ISO 13485, QMSR, and FDA Part 820 out of the box. Combines ERP and QMS in one validated platform.
Pre-validated FDA/ISO 13485 platform with fast SMB implementation (3–4 months), IQ/OQ/PQ documentation included — one of the most accessible regulated-manufacturing options available.
AI score breakdown — 6 dimensions
SMB implementability 25%82
Pre-validated platform with IQ/OQ/PQ documentation included — 3–4 month typical implementation for SMB medical device companies. Self-guided pathway exists.
Purpose fit 20%88
Purpose-built for FDA-regulated manufacturers — 21 CFR Part 11, ISO 13485, and QMSR are native, not bolted on. Best-in-class for small medical device and aerospace quality environments.
Tech modernity 20%82
Modern cloud platform, clean web UI, API available. Not cutting-edge but well-suited and reliable for the regulatory environment.
Documentation quality 15%80
Good public documentation including regulatory compliance resources. Pre-sales technical materials accessible without requiring a sales call.
Real user sentiment 10%85
Consistent positive reviews from medical device and regulated aerospace SMBs. Regulatory compliance outcomes noted as strong.
TCO transparency 10%55
Published pricing tiers on website — good transparency for the regulated manufacturing segment. Full implementation cost still requires a conversation.
validate / explore this score:
Perplexity
ChatGPT
Claude
Google