Medical Device Reporting Procedure | ISO 9001:2026 + ISO 13485:2016
Assess, prepare and document manufacturer Medical Device Reports to FDA under 21 CFR Part 803. This editable medical device reporting procedure is part of the A.P. Lyon Dual-Standard QMS family for ISO 9001:2026 and ISO 13485:2016.
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Scope and intended use
This procedure applies to company devices marketed in the United States for which the company has manufacturer reporting responsibilities. For devices placed on other markets, assess separate reporting obligations under the applicable vigilance procedure, including EU MDR Article 87; an FDA MDR does not fulfill EU reporting requirements.
What you receive
One digital ZIP containing the editable SOP 8-006-C Word procedure and a PDF copy. The gallery shows representative pages from the document.
Additional editable files included in this ZIP:
FORM 0021-C.docx
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Related procedures
These procedures address connected work and are sold separately:
Systems containing this procedure
A system package includes this procedure with other documents. Review its content list before purchasing both.
Before implementation
Adapt responsibilities, process steps, acceptance criteria and records to your organization, device and intended markets. Confirm the applicable standards and regulatory requirements before approval and use. This download supplies documentation, not executed testing, regulatory authorization or certification.
