There is no evidence-based universal winner for a 200-person Class II device manufacturer. Build a shortlist, then compare vendors by having each demonstrate the same real workflows and provide a scope-matched implementation plan and three-year cost model. Use FDA’s current QMSR and ISO 13485:2016 as the regulatory baseline—not a vendor feature list.
Start with the regulatory baseline
As of February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) is in effect. It amends the device current good manufacturing practice requirements in 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. Where ISO 13485 conflicts with the Federal Food, Drug, and Cosmetic Act or its implementing regulations, the statute or regulation controls. FDA also incorporates clause 3 of ISO 9000:2015 for terms and definitions. FDA’s QMSR final rule and QMSR overview explain the change.
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Whether QMSR applies depends on the company’s role and products. FDA describes its scope as finished-device manufacturers intending to commercially distribute devices; a finished device may be suitable for use or capable of functioning whether or not it is packaged, labeled, or sterilized. Confirm applicability and any exemptions for the specific business and products rather than assuming employee count or a Class II label answers the question. FDA’s scope guidance provides the regulatory framing.
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A free scan shows the junk files, broken settings and background clutter dragging Windows down - then fixes them in one click.Free scan · Windows 10 & 11Keep eQMS procurement separate from the premarket pathway. FDA says most Class II devices require Premarket Notification (510(k)), but exceptions exist. Software can support applicable design, change, traceability, and quality records; buying it does not determine whether a particular device needs a 510(k). FDA’s 510(k) overview describes that pathway.
#1 Best Overall
Inspection context changed with QMSR’s effective date: FDA began using Inspection of Medical Device Manufacturers Compliance Program 7382.850 and ceased using QSIT and the older listed inspection programs on February 2, 2026. FDA’s QMSR information covers the transition.
What to test in an eQMS demonstration
Ask each vendor to demonstrate your actual processes with comparable sample records, not just present a feature checklist. The quality team should define which needs are mandatory now and which are future enhancements.
- Documents and training: Author and approve a controlled document, set its effective date and revision, and assign read-and-understood training.
- Change control: Trace a change across procedures, product records, suppliers, and any resulting training.
- Nonconformance and CAPA: Show intake, investigation, corrective and preventive actions, effectiveness checks, and closure.
- Complaints and post-market work: Demonstrate complaint handling and links to any applicable escalation or post-market process.
- Supplier controls: Show qualification, monitoring, and records, including contract manufacturers where relevant.
- Design and risk: For products where these controls apply, trace a design change to the risk file and related records.
- Records and access: Inspect audit trails, roles and permissions, electronic signatures, and record export.
- Delivery and ownership: Establish migration effort, implementation support, integrations, validation documentation, user training, and support response.
- Cost over time: Include subscriptions, seats, modules, onboarding, migration, integrations, services, and renewal changes over the expected contract term.
These are evaluation criteria, not claims that every shortlisted product handles each function equally. Vendor pages describe vendors’ own offerings; request demonstrations of identical scenarios and documentation explaining how you can validate the software for its intended use.
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Which vendors belong on the shortlist?
Four vendors have product pages relevant to medical-device quality management: Greenlight Guru, Qualio, MasterControl, and Veeva. The published material establishes that they market relevant products; it does not establish comparative fit, regulatory compliance, or a best choice for a 200-person company.
Rank #3
| Candidate | What its published page says | What to verify |
|---|---|---|
| Greenlight Guru | Its pricing page describes an eQMS for medical-device companies aligned to ISO 13485, FDA QMSR, ISO 14971, and IEC 62304. It says packages start at $12,000 per year and describes connected quality workflows and vendor-provided release validation documentation. Greenlight Guru pricing | The $12,000 annual figure is a vendor-published starting price, not a quote or complete cost for a 200-person organization. Confirm included modules, seats, onboarding, migration, and other charges. |
| Qualio | Its medical-device page describes a cloud quality system for device companies. Its pricing page says subscriptions are annual and tailored to operational needs; it does not provide an equivalent public price in the reviewed material. Qualio medical-device product · Qualio pricing | Request a quote using the same users, locations, modules, migration scope, and services as for other candidates. |
| MasterControl | Its product page markets a medical-device eQMS called Quality Excellence. MasterControl medical-device quality | The product page alone does not establish fit, implementation burden, or comparative value for this company size. |
| Veeva | Its medtech page markets a unified global quality management system for medtech quality teams. Veeva medtech | The product page does not establish that it is better or worse for a 200-person company. |
Do not treat vendor claims as independent validation. The manufacturer remains responsible for its quality system, procedures, and records, and for determining whether a software system is suitable for its intended use.
Run a comparable selection process
- Map current work. List the procedures, records, and workflows the system must support. Separate mandatory requirements from future nice-to-haves.
- Choose three or four candidates. Give each the same realistic scenarios: a document revision that requires retraining; a supplier issue that becomes a nonconformance and CAPA; a design change affecting a risk file; and a complaint requiring escalation.
- Score what the team observes. Include workflow fit, traceability, ease of use, records and export, integration, implementation effort, support, and total cost. Include quality, regulatory, operations, IT/security, and representative end users.
- Require written delivery details. Ask for an implementation plan, migration assumptions, role and configuration model, validation documentation, security information, support and service terms, and a three-year cost model.
- Check comparable references. Seek customers with a similar product lifecycle, manufacturing model, and regulatory markets. The available evidence does not establish an independent head-to-head study, implementation outcome, or reference specific to a 200-person Class II manufacturer.
What the evidence does—and does not—support
The named vendors are reasonable candidates to investigate, not a ranked recommendation. Available product and pricing pages do not provide a uniform basis for comparing implementation outcomes or three-year costs. No hands-on trial or comparable quotation exercise establishes which system would fit this company best, so the decision should follow the same scripted demonstrations and written cost and implementation assumptions for every finalist.
Rank #4
FDA’s economic analysis estimated aggregate annualized net cost savings from the QMSR rule of $532 million at a 7 percent discount rate and $554 million at a 3 percent discount rate. Those are FDA’s estimates for the rule, not savings for an individual company or a projected return on investment from eQMS software. FDA’s 2024 final rule contains the economic analysis.
For background reading, FDA links to an AAMI/ISO 13485:2016 practical guide. A standard or handbook can help a team understand requirements; owning one does not itself establish compliance. FDA’s QMSR page links to the guide.
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