Software as a Medical Device Development | ISO 9001:2026 + ISO 13485:2016
Control Software as a Medical Device planning, development, verification, validation, release, maintenance and retirement. This editable software as a medical device development 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 software intended to perform a medical purpose independently of a hardware medical device, including software developed by suppliers. Device qualification, risk class, submission route and lifecycle activities shall be determined separately for each intended market and product. Changes to intended purpose, algorithm, data, platform or delivery method shall trigger reassessment.
What you receive
One digital ZIP containing the editable SOP 7-043-C Word procedure and a PDF copy. The gallery shows representative pages from the document.
No separate editable form or controlled-list files are included in this individual ZIP. Review the procedure and gallery for its embedded attachments and references.
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.
