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The backbone of an ISO 13485 / FDA QMSR quality system, ready to tailor. Six core procedures plus a Quality Manual — the foundation a device or IVD startup needs to build a compliant QMS without starting from a blank page.
A Quality Manual template (scope, policy, structure, and a clause-to-procedure map).
Six tailorable procedures (Word): Control of Documents, Control of Records, Management Review, Training & Competence, Internal Audit, and Purchasing & Supplier Control.
A suite tailoring guide with the exact order to stand up your system.
Single-organization license; edit and co-brand for internal use.
Medical device and IVD startups and lean teams standing up a quality system, and quality professionals who want a compliant, consistent backbone instead of writing every SOP from scratch.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Because this is an instant digital download, all sales are final and non-refundable. If a file won’t download or appears corrupted, email aaron.vant@medevexconsulting.com and we’ll make it right. Single-organization license; not for resale or redistribution.The backbone of an ISO 13485 / FDA QMSR quality system, ready to tailor. Six core procedures plus a Quality Manual — the foundation a device or IVD startup needs to build a compliant QMS without starting from a blank page.
A Quality Manual template (scope, policy, structure, and a clause-to-procedure map).
Six tailorable procedures (Word): Control of Documents, Control of Records, Management Review, Training & Competence, Internal Audit, and Purchasing & Supplier Control.
A suite tailoring guide with the exact order to stand up your system.
Single-organization license; edit and co-brand for internal use.
Medical device and IVD startups and lean teams standing up a quality system, and quality professionals who want a compliant, consistent backbone instead of writing every SOP from scratch.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Because this is an instant digital download, all sales are final and non-refundable. If a file won’t download or appears corrupted, email aaron.vant@medevexconsulting.com and we’ll make it right. Single-organization license; not for resale or redistribution.