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Documents to review
Quality manualResearch document type
Capa procedureResearch document type
Complaint procedureResearch document type
Design control procedureResearch document type
Supplier control procedureResearch document type
Scope questions
Industry alone does not establish legal applicability. Confirm location, activities, role, data and relevant thresholds.
Where does the organization operate, and which regulator, license, permit or contract governs the activity?
Which business activities, data types and organization roles does the document describe?
Do the relevant thresholds or exceptions change which requirements apply?
Unknown answers stay unresolved. Document detection does not answer these questions for you.
A fictional example to explore
This short policy outline demonstrates the document's structure and research questions. It is a navigation example; scans for this profile are not available yet.
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Regulations and frameworks to explore
These are research candidates for this profile. Confirm the exact organization and activity before concluding that a rule applies.
Research only
FDA Quality Management System Regulation
21 CFR Part 820 · ISO 13485:2016 incorporated by reference
QMSR is effective from February 2, 2026. Confirm the device-manufacturer role and applicable requirements of 21 CFR Part 820; ISO 13485:2016 is incorporated by reference and its text remains rights-sensitive.
Jurisdictions: US-FEDERAL
Research applicability questions
What medical-device manufacturing role places the organization within FDA QMSR scope?
Which device classifications and product-specific regulatory requirements apply?
Which design, manufacturing, servicing or other operations are covered by the quality-system boundary?
Do any device-specific exemptions apply, and which quality-system duties remain?
Applies to electronic records and signatures within the scope of FDA predicate-rule record requirements and qualifying electronic submissions. It is not a universal rule for every electronic business document. Identify the predicate rule, record/signature use and system before assessing requirements.
Jurisdictions: US-FEDERAL
Research applicability questions
Which FDA predicate rule requires these records to be maintained or submitted?
Are required records maintained/submitted electronically rather than only paper records or convenience copies?
Are electronic signatures used in place of signatures required by the applicable FDA rules?
ISO 13485:2016 identifies a medical-device quality-management standard. Confirm the organization’s device lifecycle role, certification boundary and applicable market rules. FDA QMSR incorporates this edition for covered US device manufacturers, but certification alone does not establish FDA compliance. Requirement-text use remains subject to licensing.
Jurisdictions: GLOBAL
Research applicability questions
Do you design, manufacture, install, service or supply medical devices, and within which certification boundary?
Which national device regulations or customer contracts require this standard for that role?