{"product_id":"iso-13485-qms-in-a-box-design-only","title":"ISO 13485 QMS-in-a-Box — Design-Only \/ R\u0026D Entity","description":"\u003cp\u003eDesign-only organizations are often forced into generic QMS models that overbuild manufacturing controls while still leaving Clause 7.3, DHF integrity, and design-transfer logic exposed. This design-only edition hard-locks Clause 7.3 expectations, DHF integrity, and design-transfer boundaries so teams can build an audit-defensible development system without unnecessary manufacturing content. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.\u003c\/p\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eGovernance and Use Guide.pdf\u003c\/li\u003e\n\u003cli\u003eImplementation Sequence.pdf\u003c\/li\u003e\n\u003cli\u003eRegulatory Role Definitions.pdf\u003c\/li\u003e\n\u003cli\u003eClause Applicability Matrix.xlsx\u003c\/li\u003e\n\u003cli\u003eMandatory vs Optional Records.xlsx\u003c\/li\u003e\n\u003cli\u003eAudit Exposure Risk Map.pdf\u003c\/li\u003e\n\u003cli\u003eInternal Audit Doctrine.pdf\u003c\/li\u003e\n\u003cli\u003eInternal Audit Framework.pdf\u003c\/li\u003e\n\u003cli\u003eInternal Audit Execution Checklists.pdf\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eBest suited to:\u003c\/strong\u003e R\u0026amp;D team, Startup manufacturer, Quality manager, and Regulatory consultant.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eUseful in audit situations where you need to:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eShow a structured design-only ISO 13485 implementation process during ISO 13485 certification, surveillance, supplier, or internal audits.\u003c\/li\u003e\n\u003cli\u003eSupport FDA inspections with controlled records, traceability, and process evidence related to design-only ISO 13485 implementation.\u003c\/li\u003e\n\u003cli\u003eSupport EU MDR technical documentation or quality-system reviews where design-only ISO 13485 implementation records need to be complete, controlled, and consistent.\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eUse this design-only edition to implement the right controls in the right order and present a cleaner design-control model to certification auditors and investors.\u003c\/p\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":46615995908290,"sku":"ISO 13485 QMS-in-a-Box — Design-Only \/ R\u0026D Entity","price":1290.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_Createasquarepremiumproductthumbnailfor_ISO13485QMS-in-a-Box-Design-Only-74305.png?v=1773430797","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-qms-in-a-box-design-only","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}