Both platforms serve medical device companies — but they start from fundamentally different assumptions about who you are and where your business is going. Here is an honest, side-by-side look at what each platform does best and where each falls short.
Greenlight Guru is a thoughtfully built QMS for medical device companies that know they will operate solely in the medtech vertical for the foreseeable future. It covers DHF, DMR, and 21 CFR Part 820 workflows well, and its community and support resources are strong for that audience. Affinity QMS is the better choice when your organization spans more than one regulated industry, when built-in validation protocol generation matters, or when early-stage pricing is a real constraint. If you are a pure-play medtech startup with no plans to touch food, supplements, or lab operations, Greenlight Guru deserves serious consideration. If your compliance footprint is or may become cross-vertical, Affinity QMS is the more durable platform.
Ten attributes that matter most to quality and regulatory teams at early-stage and growing companies.
| Attribute | Affinity QMS | Greenlight Guru |
|---|---|---|
| Verticals covered | ✓ 6 regulated industries (medical devices, supplements, OTC drugs, 503B, ISO 17025 labs, food & beverage) | ✗ Medical devices only |
| Entry-level pricing | ✓ $499/mo — publicly listed, no sales call required | — Not publicly listed; typically $500+/mo based on market reports |
| Built-in validation protocols (IQ/OQ/PQ) | ✓ Auto-generated by Validation Protocol Engine — included in platform | — Not a native feature; typically handled externally or via consultants |
| Configuration flexibility | ✓ Adapts to your existing processes at onboarding | — Opinionated workflow structure designed around medtech best practice |
| Implementation time | ✓ Days to weeks | — Weeks to months depending on configuration |
| ISO 13485 support | ✓ Full support — built-in controls and audit trails | ✓ Full support — core part of the platform |
| FDA QMSR support | ✓ Full support | ✓ Full support |
| DHF / DMR management | ✓ Dedicated DHF/DMR module included | ✓ Strong native DHF/DMR — a core differentiator for Greenlight Guru |
| Certification expandability | ✓ SQF, NSF, BRC, FSSC 22000, A2LA, PCAB, USP, and more | ✗ Medical device certifications only (MDSAP, MDR, UKCA) |
| Startup-native architecture | ✓ Built from the ground up for startups and growing companies | — Well-suited for medtech startups, but single-vertical by design |
Greenlight Guru built a reputation in the medtech community by focusing exclusively on the needs of medical device companies. That single-vertical focus shows in the product: the DHF and DMR workflows are well-considered, the regulatory audit trails are solid, and the company understands the 510(k) and PMA pathways at a deep level. For a device startup whose founders came from legacy QMS tools like MasterControl or Arena, Greenlight Guru feels considerably lighter to operate.
The limitation of that single-vertical focus becomes apparent when your business evolves. Device companies frequently spin up companion businesses — a supplement line built on the same manufacturing floor, a co-manufacturing arrangement with a food facility, or a diagnostic lab running ISO 17025. Each of those expansions would require a second QMS subscription with Greenlight Guru. With Affinity QMS, they expand within the same platform.
Pricing transparency is a meaningful operational difference. Affinity QMS publishes its pricing at $499/mo entry with a clear module-based expansion path. Greenlight Guru does not publish pricing publicly, which means your team will spend time in a sales process before understanding the cost. For a founder managing a tight runway, the time cost of that sales cycle matters.
The validation protocol gap is significant for device companies using computer-based systems that require IQ/OQ/PQ documentation. Affinity QMS generates these protocols natively through the Validation Protocol Engine. Greenlight Guru users typically handle validation documentation externally — either through consultants or manual document creation — which adds cost and risk at a moment when most device startups are already stretched thin on regulatory resources.
On the core medtech compliance requirements — 21 CFR Part 820, ISO 13485, FDA QMSR, CAPA, document control — both platforms perform competently. If your evaluation is purely within the medical device vertical and you have no plans to expand, the decision between these two platforms will come down to DHF workflow depth (Greenlight Guru), pricing transparency (Affinity QMS), and validation protocol support (Affinity QMS).
Transparent pricing is a competitive advantage for startup QA teams managing tight budgets.
Publicly listed entry pricing. No sales call required to understand cost. Module-based expansion — pay for what you use. Custom enterprise pricing available for larger organizations. Startup plan includes QMS Core, Document Control, CAPA, and one vertical configuration.
View Full PricingPricing requires a sales conversation. Based on market reports and user community data, entry pricing typically falls in the $500–$1,500+/mo range depending on user count and feature set. Annual contracts are standard. The lack of published pricing requires a sales cycle before your team can conduct a cost comparison.
Book a 30-minute live demo. We will walk through the medical device vertical, DHF/DMR workflows, and the Validation Protocol Engine — no sales pressure, just the platform.