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Usually, no. FDA does not generally require a software-as-a-medical-device (SaMD) company to buy or deploy a commercial electronic quality management system (eQMS) to obtain clearance. But that is not permission 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 format.
What FDA requires—and what it does not
FDA’s Quality Management System Regulation (QMSR) establishes quality-system requirements for finished-device manufacturers intending to commercially distribute medical devices, subject to applicable scope and exemptions. It does not set a general requirement to purchase an eQMS. A company may use suitable controlled documents and other tools instead, provided its system meets the requirements that apply and it can maintain and retrieve the necessary records.
The distinction is important: “a QMS is required” does not mean “an eQMS subscription is required,” and “an eQMS is optional” does not mean quality documentation can be informal, uncontrolled, or missing.
QMSR is now the current U.S. framework
As of October 4, 2026, QMSR has been effective since February 2, 2026. It amends 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. FDA’s overview says the regulation applies to finished-device manufacturers intending commercial distribution. Scope and obligations depend on the device, the company’s activities, and any applicable exemptions.
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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 & 11FDA describes a finished device broadly as a device or accessory suitable for use or capable of functioning, whether packaged, labeled, or sterilized. Some components can themselves be finished devices. Certain classifications have CGMP exemptions, but an exemption does not necessarily remove all record or complaint-file obligations. Devices manufactured under an investigational device exemption are not exempt from design and development requirements. Check the applicable rules for the specific product rather than assuming a startup’s stage settles the question.
How clearance timing relates to quality-system work
Premarket review and permission to commercially distribute are separate questions. FDA’s 510(k) overview says a device that requires a 510(k) cannot be commercially distributed until FDA issues a substantial-equivalence letter. That does not establish a general rule that every quality-system record must be submitted with every premarket notification.
The pathway depends on the product’s software function, intended use, risk, classification, and other product-specific facts. FDA’s broad overview says most Class I devices are exempt from premarket notification, most Class II devices require 510(k), and most Class III devices require a PMA; those generalizations do not determine the pathway for an unnamed SaMD.
FDA’s October 2025 page on Quality Management System Information for Certain Premarket Submission Reviews is explicitly marked Draft and “Not for implementation. Contains non-binding recommendations.” It is not settled final policy.
What an eQMS can manage
An eQMS is one way to organize controlled procedures and applicable records. Depending on the company’s operations, these may include design and development evidence, risk files, training records, supplier controls, nonconformances, corrective and preventive action (CAPA), complaints, and change control. The right scope follows the product and activities; a software platform does not define which obligations apply.
A company using simpler tools should be able to show that its processes are controlled and that records remain reliable, accessible, and retrievable. In practice, that means deciding who owns each process, controlling document versions and approvals, preserving change history, and avoiding unmanaged copies or gaps. These are practical ways to implement a system, not an FDA-prescribed startup sequence.
When dedicated eQMS software may be useful
There is no FDA-mandated team size, record count, or maturity milestone at which a startup must switch to an eQMS. The choice is operational: consider whether current tools can support the company’s real workflows and preserve the evidence it needs.
| Decision area | Questions to ask |
|---|---|
| Process fit | Can the tools support applicable design, risk, document, training, supplier, nonconformance, CAPA, complaint, and change-control workflows? |
| Traceability and history | Can the company show approvals, revisions, training completion, linked records, and an understandable change history? |
| Access and record integrity | Can permissions, review, approvals, retention, retrieval, and record export be managed for the company’s needs? |
| Integration and growth | Will the approach work with development, issue-tracking, testing, supplier, and product systems without creating uncontrolled copies or gaps? |
| Implementation burden | Can the company manage configuration, migration, training, maintenance, vendor dependence, and ongoing process overhead? |
A dedicated platform may help when the number of workflows, users, records, or integrations makes the existing approach difficult to control. It also adds implementation and maintenance work. Evaluate the actual fit rather than treating software adoption as evidence of compliance.
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Software used to run the quality system has 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. The underlying regulation requires validation of software for its intended use when it is used as part of production or the quality system, including applicable cloud services. The guidance discusses software that automates QMS processes, processes QMS data, or maintains required quality records; supporting software may warrant less assurance when its risk is lower.
For each system, identify what the company intends to rely on it to do, which workflows and records are in scope, and what could happen if it fails. Consider access and approvals, change handling, audit trails, record export and retrieval, and supplier evidence that supports the company’s own assurance. FDA’s risk-based approach does not certify a vendor or make a particular platform compliant by itself.
Certification does not replace compliance
QMSR incorporates ISO 13485:2016, but that does not make a commercial eQMS or an ISO 13485 certificate a substitute for meeting FDA requirements. FDA says it does not require or issue ISO 13485 certificates of conformance, and its QMSR FAQ states: “A certificate of conformance to ISO 13485 will not exempt a manufacturer from an FDA inspection.”
A practical way to decide
- Establish the regulatory context. Identify the software function, likely U.S. pathway, commercial plans, and product-specific scope or exemptions. Seek qualified regulatory advice where those facts are uncertain.
- Map the work and records. Determine which quality processes apply to the company’s current activities and assign accountable owners.
- Choose tools that can control the system. Use controlled documents or dedicated software according to workflow, team, risk, traceability, and record needs—not because a platform is assumed to be a clearance prerequisite.
- Assess software used in regulated workflows. Define intended use and apply risk-based assurance when software automates QMS work, processes QMS data, or maintains required records.
- Reassess as the company changes. Product development, suppliers, team size, workflows, and commercial plans can change what the system needs to support; maintain applicable records for inspection.
FDA’s older Content of Premarket Submissions for Device Software Functions guidance provides software-submission context and notes that design and development elements are addressed in ISO 13485 Clause 7.3 and its subclauses. It predates QMSR’s effective date and directs manufacturers to review current QMSR, so use the current rule for present obligations.
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