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Usually, no. FDA does not generally require a SaMD company to buy or deploy a commercial electronic quality management system (eQMS) as a condition of clearance. But that is not the same as being free to postpone applicable quality-system work: the company needs appropriate controlled processes and records for its product and activities. FDA regulates the quality system, not a particular software brand or electronic format.
What FDA requires—and what it does not
As of October 2026, FDA’s Quality Management System Regulation (QMSR), 21 CFR Part 820, has been effective since February 2, 2026. It incorporates ISO 13485:2016 by reference. FDA says the QMSR applies to finished-device manufacturers that intend to commercially distribute medical devices, subject to scope and exemptions. FDA’s QMSR overview describes the regulation as a basic requirement for device manufacturers distributing in the United States.
That obligation concerns the quality system. FDA’s published materials do not make purchasing a dedicated eQMS a general prerequisite for clearance. A company may use appropriately controlled documents and other tools if they support the processes and records its situation requires; simply keeping informal, uncontrolled files would not establish that those needs are met.
Scope is product- and activity-specific. FDA’s overview says most Class I devices are exempt from premarket notification, most Class II devices require 510(k), and most Class III devices require PMA. Those general patterns do not establish the pathway for a particular software function. Intended use, classification, commercial plans, exemptions, and the company’s role all matter. FDA also says devices manufactured under an investigational device exemption are not exempt from design and development requirements, and a CGMP exemption does not necessarily remove every record or complaint-file obligation. Check the applicable rules and product facts rather than inferring that a startup’s premarket stage settles the question.
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FDA’s device-regulation overview distinguishes premarket review from distribution: if a device requires a 510(k), it cannot be commercially distributed until FDA issues a substantial-equivalence letter. Clearance is therefore a distribution gate when that pathway applies—not a blanket rule that quality-system work begins only after clearance.
Can a company use controlled documents instead of eQMS software?
Potentially, yes. An eQMS is one way to manage applicable procedures and records; it is not itself the quality system. Depending on the company’s operations, relevant work may include design and development evidence, risk records, document approvals and revisions, training, supplier controls, nonconformances, corrective and preventive action (CAPA), complaints, and change control. The exact set depends on the product and activities.
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A smaller team may be able to manage its needs with simpler tools if it can reliably control versions and approvals, preserve record history, restrict access as needed, and retrieve records. These are practical implementation considerations, not an FDA-endorsed startup maturity rule. As workflows, team size, record volume, auditability needs, or integrations become more demanding, a dedicated platform may be useful. Buying one does not by itself make the company compliant.
How to decide whether to adopt an eQMS
- Establish the regulatory context. Identify whether the software function is a regulated device, its likely US pathway, commercial intent, and any product-specific exemptions or requirements.
- Map the work and records. List the quality processes relevant to current activities, assign accountable owners, and decide how records, approvals, revisions, and retrieval will be controlled.
- Choose tools to fit the work. Compare controlled-document workflows or other existing tools with dedicated eQMS software on process fit, traceability, access, record integrity, retention, export, integration, implementation burden, and vendor dependency.
- Reassess as the business changes. Revisit the choice when the product, team, suppliers, workflows, or commercial plans change, and maintain applicable records for potential FDA inspection.
This is a practical decision sequence, not a prescribed FDA startup sequence. The useful question is whether the chosen approach can support the company’s actual quality processes and records—not whether it has a particular product category of software.
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If the eQMS is software used in regulated work
Software used to run a quality system brings its own assurance question. FDA’s final Computer Software Assurance for Production and Quality Management System Software guidance, issued February 3, 2026, describes a risk-based approach. FDA says applicable regulation requires validation of software for its intended use when used as part of production or the quality system, including applicable cloud services. Examples include software that automates QMS processes, processes QMS data, or maintains required quality records. Supporting software may warrant less assurance effort when its risk is lower.
The guidance contains nonbinding recommendations; it does not make an eQMS mandatory or certify vendors. Before relying on a product, define its intended uses and the workflows and records in scope. Consider how it handles permissions, approvals, change history, record export and retrieval, and what supplier evidence is available to support the company’s own risk-based assurance.
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Does ISO 13485 certification replace compliance?
No. QMSR incorporates ISO 13485:2016, but FDA says it does not require or issue ISO 13485 certificates of conformance. FDA’s FAQ states: “A certificate of conformance to ISO 13485 will not exempt a manufacturer from an FDA inspection.” Certification is not a substitute for meeting applicable FDA requirements, and a vendor’s platform cannot guarantee that a company’s QMS complies. See FDA’s QMSR frequently asked questions.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What is—and is not—established about premarket submissions
Do not assume every quality-system record must be submitted with every premarket notification. FDA’s October 2025 page on Quality Management System Information for Certain Premarket Submission Reviews labels the document a draft, says it is “Not for implementation,” and identifies its recommendations as nonbinding. It is not settled final policy.
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For software-submission context, FDA’s Content of Premarket Submissions for Device Software Functions discusses design and development evidence and notes the current QMSR. Because it predates QMSR’s effective date, use the current regulation for present quality-system obligations.
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