QMS scope, regulatory burden, and compliance obligations vary significantly by entity type and business stage. We help every category of medical device company — and our QMS Applicability Matrix illustrates generally what's in scope for yours; however, the nuances and details will be guided by the uniqueness of your operation.
A common failure mode in medical device consulting is to treat every client like a US manufacturer building a Class III device from scratch — applying every QMS clause, demanding full design controls, and pricing the engagement accordingly.
The reality is that what applies to you depends on who you are. An EU distributor does not need design controls. A US importer has different reporting obligations than a foreign manufacturer. A repackager has a specific subset of production, labeling, and traceability requirements.
We start every engagement by establishing what's actually in scope for your entity type — then we build, remediate, or assess only what regulation requires you to operate. Often we find ways to "trim the fat" from processes previously implemented that serve no purpose or add no value to the organization.
The QMS scope, US-specific obligations, and EU-specific obligations that apply to your organization are determined by your role.
Full QMS under 21 CFR 820 / QMSR — design controls, production, complaint handling, and post-market obligations.
Full QMS plus US-specific obligations including Establishment Registration, US Agent appointment, and GUDID maintenance.
Importer obligations including Establishment Registration, Receiving Inspection, complaint handling, and reportable events.
Distribution role under EU MDR with QMS scope focused on storage, traceability, complaint handling, and EU reportable events.
QMS scope centered on labeling, packaging, traceability, and post-market reporting — typically without design controls.
Lightest QMS scope — primarily a Supplier Quality Agreement with the manufacturer or importer of record.
QMS scope depends on agreement scope — but typically includes production controls, supplier quality, and traceability under a Quality Agreement with the device owner.
Human cell, tissue, and cellular and tissue-based product establishments — subject to 21 CFR Parts 1270/1271 with specific Good Tissue Practice requirements.
Your business stage shapes the kind of engagement that works. We adapt to where you are — and the pace at which you're moving.
Venture-backed or founder-led companies bringing a first device to market. Typically pre-revenue or early-revenue, focused on the first major regulatory milestone.
Companies that have launched a first product and are scaling — adding products, entering new markets, hiring quality and regulatory leadership, or preparing for audit cycles.
Mature device companies with commercialized portfolios. Engagements often involve remediation, transition projects, or specialized expertise to supplement internal teams.
US-domiciled and international companies operating across multiple regulatory jurisdictions, with the complexity of managing different requirements in parallel.
The matrix below maps QMS requirements, US-specific obligations, and EU-specific obligations against each entity type. Use it as a starting point — every engagement we run begins with a detailed applicability assessment specific to your products, markets, and risk classification.
An important note on applicability. This matrix reflects typical scope for each entity type but is not a substitute for a regulatory assessment. Actual obligations depend on device classification, intended use, jurisdiction, and supply chain structure. Cells marked "As Applicable" or "Conditional" frequently apply but require evaluation. Cells marked "—" are typically out of scope but may apply in specific configurations. We start every engagement with a detailed applicability assessment for your specific products and markets.
| Requirement | US Importer · Distributor |
EU Distributor |
Repackager · Relabeler |
US Manufacturer |
Foreign Manufacturer |
US Distributor |
|---|---|---|---|---|---|---|
| Quality Management System | ||||||
| Quality Manual | Y | Y | Y | Y | Y | — |
| Quality Planning | Y | Y | Y | Y | Y | — |
| Management Review | Y | Y | Y | Y | Y | — |
| Good Document Practices | Y | Y | Y | Y | Y | — |
| Document Control | Y | Y | Y | Y | Y | — |
| Training | Y | Y | Y | Y | Y | — |
| Quality System Audit | Y | Y | Y | Y | Y | — |
| Design Control | — | — | — | Y | Y | — |
| Risk Management | Y | Y | Y | Y | Y | — |
| Process Validation | — | — | Y | Y | Y | — |
| Software Validation | — | — | — | As Appl. | As Appl. | — |
| Production Control | As Appl. | — | As Appl. | Y | Y | — |
| Receiving Inspection | Y | Y | Y | Y | Y | — |
| Monitoring & Measuring Equipment | If Appl. | As Appl. | Y | Y | Y | — |
| Data Analysis & Statistical Methods | — | — | — | Y | Y | — |
| Nonconforming Material Control | Y | Y | Y | Y | Y | — |
| Supplier Control | Y | Y | Y | Y | Y | — |
| Purchasing Control | Y | Y | Y | Y | Y | — |
| Supplier Corrective Action | Y | Y | Y | Y | Y | — |
| Rework | — | — | As Appl. | As Appl. | As Appl. | — |
| Inventory Control (Traceability) | Y | Y | Y | Y | Y | — |
| Packaging, Labeling, Handling, Distribution | Y | As Appl. | Y | Y | Y | — |
| Product Identification (PN / Lot) | Y | Y | Y | Y | Y | — |
| Product Returns | Y | Y | Y | Y | Y | — |
| Complaint Handling & Customer Feedback | Y | Y | Y | Y | Y | — |
| Corrective & Preventive Action (CAPA) | Y | Y | Y | Y | Y | — |
| Reportable Events | Y | EU | Y | Y | Y | — |
| Field Action | Y | Y | Y | Y | Y | — |
| Supplier Quality Agreement | ||||||
| Supplier Quality Agreement | Y | Y | Y | Y | Y | Y |
| US-Specific Obligations | ||||||
| Establishment Registration | Y | — | Y | Y | Y | — |
| US Agent | — | — | — | — | Y | — |
| GUDID Submission & Maintenance | — | — | Y | Y | Y | — |
| EU-Specific Obligations | ||||||
| Authorized Representative (EU) | — | — | — | Y | Unless EU | — |
| EUDAMED Registration & Submissions | — | — | — | Y | Y | — |
| Notified Body Engagement | — | — | — | Unless Class I | Unless Class I | — |
Most companies operate as more than one entity type — a foreign manufacturer that also distributes in the US, for example. Schedule a consultation and we'll help you sort it out.
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