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Greenlight Guru

AI score: 87 / 100 Exceptional for SMB

QMS software purpose-built for medical device companies

Type: plug-ins / best-of-breed  ·  Tech: modern  ·  Budget: SMB friendly ($10k–$70k/yr)
Core verticals: medical / bioscience
Functions: quality

Not an ERP — a quality management system for medical device manufacturers. Pre-validated for FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR. Strong in DHF, DMR, CAPA, and complaint management.

editor's note: This is a QMS, not a full ERP. It excels at what it does — regulatory compliance and quality records for medical device companies — but you'll still need a separate ERP for production and financials.

Best purpose-built medical device QMS for SMB teams — weeks-to-live onboarding, strong DHF/DMR workflows; penalized for significant 2025 price hikes, no public pricing, and multi-year contractual lock-in.

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AI score breakdown — 6 dimensions

SMB implementability 25%85
Weeks-to-live onboarding for medical device QMS — template-driven approach, self-guided setup. Narrow scope (QMS only) means faster implementation than full ERP.
Purpose fit 20%95
Best-in-class medical device QMS — DHF, DMR, CAPA, and complaint management workflows are purpose-designed for FDA 21 CFR Part 820 and ISO 13485:2016. Nothing else is more purpose-fit for this niche.
Tech modernity 20%88
Modern cloud-native platform, clean UI, strong API integrations with product development tools. Active product development team.
Documentation quality 15%72
Good documentation but some resources gated. Knowledge base available to customers. Pre-sales transparency is moderate.
Real user sentiment 10%87
Strong G2 reviews from medical device SMBs. Implementation and support quality differentiated from enterprise alternatives. 2025 price increases are appearing in recent reviews.
TCO transparency 10%35
No public pricing — significant 2025 price hikes and multi-year commitment patterns make TCO harder to estimate. Community reports substantial increase from earlier pricing.

Sources consulted

validate / explore this score: Perplexity ChatGPT Claude Google

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