{"title":"ISO 13485 Medical Device QMS Templates","description":"\u003cp\u003eEditable ISO 13485 and ISO 14971 templates for medical device manufacturers, distributors and design-only companies: document control, design controls and DHF, CAPA and complaints, supplier control, internal audit, risk management, training kits and complete QMS-in-a-Box systems. Instant download in Word and Excel, licensed for one organization.\u003c\/p\u003e","products":[{"product_id":"document-control-system-bundle","title":"Document Control System Bundle","description":"\u003c!-- Document Control System Bundle --\u003e\n\u003cdiv\u003e\n  \u003ch2\u003eWho This Kit Is For\u003c\/h2\u003e\n  \u003cp\u003e\n    Organisations needing a full document control framework, not just training, including SOPs, master lists and change control tools.\n  \u003c\/p\u003e\n\n  \u003ch2\u003eThe Compliance Problem It Solves\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eAd hoc document control with multiple spreadsheets and no single source of truth.\u003c\/li\u003e\n    \u003cli\u003eUntraceable changes, missing approvals and uncontrolled templates.\u003c\/li\u003e\n    \u003cli\u003eAudit findings that current versions are not consistently available at points of use.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eWhat You Get In This Kit\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eDocument control SOP covering creation, review, approval, issue and obsolescence.\u003c\/li\u003e\n    \u003cli\u003eMaster Document List and change control log templates.\u003c\/li\u003e\n    \u003cli\u003eDocument numbering, classification and access control guidance.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eHow This Kit Reduces Your Audit Risk\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eProvides a single, controlled mechanism for document creation and revision aligned with clause 4.2.4.\u003c\/li\u003e\n    \u003cli\u003eImproves transparency of change history and approvals.\u003c\/li\u003e\n    \u003cli\u003eSupports consistent distribution of current documents across the organisation.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eHow To Implement It (Step-by-Step)\u003c\/h2\u003e\n  \u003col\u003e\n    \u003cli\u003eDownload the bundle and configure numbering, classifications and roles to your organisation.\u003c\/li\u003e\n    \u003cli\u003ePopulate the Master Document List and migrate existing documents into the system.\u003c\/li\u003e\n    \u003cli\u003eAdopt the change control log and process for all future document changes.\u003c\/li\u003e\n    \u003cli\u003eAudit usage regularly to ensure compliance and refine processes as needed.\u003c\/li\u003e\n  \u003c\/ol\u003e\n\n  \u003ch2\u003eTechnical \u0026amp; Regulatory Alignment\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eBuilt for: ISO 13485:2016 clauses 4.2.3 and 4.2.4.\u003c\/li\u003e\n    \u003cli\u003eTypical use: full document control across all QMS documentation.\u003c\/li\u003e\n    \u003cli\u003eDocument type: document control system bundle.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\u003c\/div\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":46005439627458,"sku":null,"price":149.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_GeminiFlash_Createasquarepremiumproductthumbnailfor_DocumentControlSystemBundle_.Show74305.png?v=1773429617"},{"product_id":"design-control-training-kit","title":"Design Control Training Kit","description":"\u003c!-- Design Control Training Kit --\u003e\n\u003cdiv\u003e\n  \u003ch2\u003eWho This Kit Is For\u003c\/h2\u003e\n  \u003cp\u003e\n    R\u0026amp;D, engineering, QA\/RA and project managers who must understand stage-gated design and development controls for medical devices and IVDs.\n  \u003c\/p\u003e\n\n  \u003ch2\u003eThe Compliance Problem It Solves\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eGaps between design activities and documented requirements of ISO 13485 clause 7.3.\u003c\/li\u003e\n    \u003cli\u003ePoorly evidenced design reviews, verification, validation and design transfer activities.\u003c\/li\u003e\n    \u003cli\u003eNew staff not understanding DHF expectations, traceability and change control during development.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eWhat You Get In This Kit\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eDesign control training slide deck covering plan, inputs, outputs, review, verification, validation and transfer.\u003c\/li\u003e\n    \u003cli\u003eTrainer guide and facilitator notes referencing your Design Control SOP and templates.\u003c\/li\u003e\n    \u003cli\u003eLearner workbook including design case studies and traceability matrix exercises.\u003c\/li\u003e\n    \u003cli\u003eAssessment pack to verify understanding of design control deliverables and responsibilities.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eHow This Kit Reduces Your Audit Risk\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eConnects everyday design work with formal design control requirements and DHF expectations.\u003c\/li\u003e\n    \u003cli\u003eSupports consistent documentation quality across projects, reducing design-related audit findings.\u003c\/li\u003e\n    \u003cli\u003eProvides demonstrable training evidence for personnel involved in design planning, execution and review.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eHow To Implement It (Step-by-Step)\u003c\/h2\u003e\n  \u003col\u003e\n    \u003cli\u003eDownload the kit and integrate examples based on your current or recent design projects.\u003c\/li\u003e\n    \u003cli\u003eDeliver training to all design team members, including QA\/RA reviewers and approvers.\u003c\/li\u003e\n    \u003cli\u003eUse workbook tasks to map real requirements, risks and tests into a sample traceability matrix.\u003c\/li\u003e\n    \u003cli\u003eFile attendance, assessment results and link training status into your Design Control SOP and training matrix.\u003c\/li\u003e\n  \u003c\/ol\u003e\n\n  \u003ch2\u003eTechnical \u0026amp; Regulatory Alignment\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eBuilt for: ISO 13485:2016 clause 7.3; supports alignment with FDA design controls and EU MDR technical documentation requirements.\u003c\/li\u003e\n    \u003cli\u003eTypical use: product development, design changes, sustaining engineering.\u003c\/li\u003e\n    \u003cli\u003eDocument type: Design control training kit.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\u003c\/div\u003e\n","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":46017143898306,"sku":null,"price":39.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_GeminiFlash_Createasquarepremiumproductthumbnailfor_DesignControlTrainingKit_.Showap74305.png?v=1773429428"},{"product_id":"document-control-training-kit","title":"Document Control Training Kit","description":"\u003c!-- Document Control Training Kit --\u003e\n\u003cdiv\u003e\n  \u003ch2\u003eWho This Kit Is For\u003c\/h2\u003e\n  \u003cp\u003e\n    Document controllers, quality coordinators and process owners who must ensure everyone understands how controlled documents are created, changed, issued and withdrawn.\n  \u003c\/p\u003e\n\n  \u003ch2\u003eThe Compliance Problem It Solves\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eAudit findings for use of obsolete SOPs, uncontrolled templates and undocumented changes.\u003c\/li\u003e\n    \u003cli\u003eStaff confusion on who can approve documents, how revisions are managed and where current versions are found.\u003c\/li\u003e\n    \u003cli\u003eWeak link between document changes, training and implementation in the QMS.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eWhat You Get In This Kit\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eTraining slide deck explaining document hierarchy, numbering, revision control and access control.\u003c\/li\u003e\n    \u003cli\u003eTrainer guide aligned with your Document Control SOP and Master Document List.\u003c\/li\u003e\n    \u003cli\u003eLearner workbook with practical exercises using sample SOPs, forms and change controls.\u003c\/li\u003e\n    \u003cli\u003eAssessment pack to confirm understanding of document control rules and responsibilities.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eHow This Kit Reduces Your Audit Risk\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eEducates all users on clause 4.2.4 requirements for document review, approval, distribution and obsolescence.\u003c\/li\u003e\n    \u003cli\u003eReduces the chance of uncontrolled documents being used in production, service or PMS.\u003c\/li\u003e\n    \u003cli\u003eSupports robust training evidence for document control roles and process owners.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eHow To Implement It (Step-by-Step)\u003c\/h2\u003e\n  \u003col\u003e\n    \u003cli\u003eDownload the kit and replace generic examples with your SOPs, WI and templates.\u003c\/li\u003e\n    \u003cli\u003eTrain document creators, reviewers, approvers and key users.\u003c\/li\u003e\n    \u003cli\u003eUse workbook exercises to walk through real document changes and approvals.\u003c\/li\u003e\n    \u003cli\u003eRecord attendance and assessment results, linking them to your training matrix and Document Control SOP.\u003c\/li\u003e\n  \u003c\/ol\u003e\n\n  \u003ch2\u003eTechnical \u0026amp; Regulatory Alignment\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eBuilt for: ISO 13485:2016 clauses 4.2.3 and 4.2.4.\u003c\/li\u003e\n    \u003cli\u003eTypical use: SOP authorship, review, approval and controlled distribution frameworks.\u003c\/li\u003e\n    \u003cli\u003eDocument type: Document control training bundle.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\u003c\/div\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":46017144029378,"sku":null,"price":39.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_Createasquarepremiumproductthumbnailfor_DocumentControlTrainingKit_.Showa74305.png?v=1773429678"},{"product_id":"internal-auditing-training-kit","title":"Internal Auditing Training Kit","description":"\u003c!-- Internal Auditing Training Kit --\u003e\n\u003cdiv\u003e\n  \u003ch2\u003eWho This Kit Is For\u003c\/h2\u003e\n  \u003cp\u003e\n    Internal auditors, process owners and QA leads who must plan, execute and report ISO 13485 internal audits with consistent technique and traceable competence.\n  \u003c\/p\u003e\n\n  \u003ch2\u003eThe Compliance Problem It Solves\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eAudit NCs citing weak internal audit programmes or untrained auditors.\u003c\/li\u003e\n    \u003cli\u003eSuperficial audit reports that do not link back to risks, processes or regulatory requirements.\u003c\/li\u003e\n    \u003cli\u003eInconsistent audit methods across auditors, making trend analysis and management review difficult.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eWhat You Get In This Kit\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eComprehensive internal audit training slide deck covering planning, execution, reporting and follow-up.\u003c\/li\u003e\n    \u003cli\u003eTrainer guide including example audit plans, checklists and interview techniques.\u003c\/li\u003e\n    \u003cli\u003eLearner workbook with process-based audit scenarios and objective evidence exercises.\u003c\/li\u003e\n    \u003cli\u003eAssessment pack to document auditor competency and qualification decisions.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eHow This Kit Reduces Your Audit Risk\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eAligns auditor skills to ISO 13485:2016 clause 8.2.4 internal audit requirements.\u003c\/li\u003e\n    \u003cli\u003eImproves the quality of findings, corrective actions and trend data used in management review.\u003c\/li\u003e\n    \u003cli\u003eProvides hard evidence that auditors are trained and assessed using a structured programme.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eHow To Implement It (Step-by-Step)\u003c\/h2\u003e\n  \u003col\u003e\n    \u003cli\u003eDownload the training materials and integrate your own audit procedures and templates.\u003c\/li\u003e\n    \u003cli\u003eConduct focused training sessions for existing and new internal auditors.\u003c\/li\u003e\n    \u003cli\u003eRun practical exercises using recent nonconformities and real audit trails.\u003c\/li\u003e\n    \u003cli\u003eFile attendance and assessment outcomes in your auditor qualification records and training matrix.\u003c\/li\u003e\n  \u003c\/ol\u003e\n\n  \u003ch2\u003eTechnical \u0026amp; Regulatory Alignment\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eBuilt for: ISO 13485:2016 clause 8.2.4; compatible with ISO 19011 auditing guidance.\u003c\/li\u003e\n    \u003cli\u003eTypical use: QMS internal audit programmes across all sites and functions.\u003c\/li\u003e\n    \u003cli\u003eDocument type: Internal audit training kit.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\u003c\/div\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":46017144062146,"sku":null,"price":39.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_GeminiFlash_Createasquarepremiumproductthumbnailfor_InternalAuditingTrainingKit_.Show74305.png?v=1773430623"},{"product_id":"risk-management-training-kit","title":"Risk Management Training Kit","description":"\u003c!-- Risk Management Training Kit --\u003e\n\u003cdiv\u003e\n  \u003ch2\u003eWho This Kit Is For\u003c\/h2\u003e\n  \u003cp\u003e\n    Quality, Regulatory and Technical leaders in medical device and IVD companies who need to train teams on ISO 14971-aligned risk management without writing training content from scratch. Ideal for start-ups, scale-ups and established manufacturers preparing for audits or certification upgrades.\n  \u003c\/p\u003e\n\n  \u003ch2\u003eThe Compliance Problem It Solves\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eInconsistent understanding of ISO 14971 terminology, risk acceptability criteria and risk files across functions.\u003c\/li\u003e\n    \u003cli\u003eAudit findings citing weak or undocumented risk management competency and inadequate training records.\u003c\/li\u003e\n    \u003cli\u003eFragmented, non-standard training slides that do not map clearly to procedures, templates or regulatory expectations.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eWhat You Get In This Kit\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eFull PowerPoint slide deck covering the complete ISO 14971 risk management process, from planning through post-production monitoring.\u003c\/li\u003e\n    \u003cli\u003eTrainer guide with speaking notes, timing guidance and workshop facilitation tips.\u003c\/li\u003e\n    \u003cli\u003eLearner workbook with exercises for risk analysis, risk evaluation and risk control scenarios.\u003c\/li\u003e\n    \u003cli\u003eAssessment pack (quiz questions, answer key and scoring guidance) to evidence competency.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eHow This Kit Reduces Your Audit Risk\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eProvides structured training content mapped to ISO 14971 and ISO 13485:2016 risk-related clauses so you can demonstrate systematic competence.\u003c\/li\u003e\n    \u003cli\u003eStandardises terminology and methods across engineering, quality and regulatory teams, reducing inconsistent risk ratings and undocumented rationales.\u003c\/li\u003e\n    \u003cli\u003eGenerates objective evidence of training and evaluation that can be linked directly to your risk management SOP and risk files.\u003c\/li\u003e\n  \u003c\/ul\u003e\n\n  \u003ch2\u003eHow To Implement It (Step-by-Step)\u003c\/h2\u003e\n  \u003col\u003e\n    \u003cli\u003eDownload the slide deck, trainer guide, learner workbook and assessment files.\u003c\/li\u003e\n    \u003cli\u003eAdapt terminology and examples to match your risk management SOP, templates and product portfolio.\u003c\/li\u003e\n    \u003cli\u003eSchedule and deliver training sessions; issue workbooks and assessments to all relevant roles.\u003c\/li\u003e\n    \u003cli\u003eMark assessments, capture attendance, file outcomes in your training records and link them to your risk management SOP and risk management plan.\u003c\/li\u003e\n  \u003c\/ol\u003e\n\n  \u003ch2\u003eTechnical \u0026amp; Regulatory Alignment\u003c\/h2\u003e\n  \u003cul\u003e\n    \u003cli\u003eBuilt for: ISO 14971:2019, ISO 13485:2016 (risk-based QMS requirements).\u003c\/li\u003e\n    \u003cli\u003eTypical use: design and development, manufacturing, PMS, vigilance, supplier qualification.\u003c\/li\u003e\n    \u003cli\u003eDocument type: Training and competence bundle (slide deck, workbook, assessment and trainer guide).\u003c\/li\u003e\n  \u003c\/ul\u003e\n\u003c\/div\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":46017144160450,"sku":null,"price":39.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_GeminiFlash_Createasquarepremiumproductthumbnailfor_RiskManagementTrainingKit_.Showa74305.png?v=1773431695"},{"product_id":"iso-13485-qms-in-a-box-startup-manufacturer","title":"ISO 13485 QMS-in-a-Box — Startup Manufacturer (Class I–IIa)","description":"\u003cp\u003eStartup manufacturers usually do not fail because one document is missing; they fail because clause applicability, sequencing, and evidence expectations were never defined early enough. This startup-manufacturer edition gives you a complete ISO 13485 operating model with clause applicability logic, mandatory-record mapping, and an enforced implementation sequence aligned to certification audit behaviour. 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 Startup manufacturer, Founder \/ CEO, 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 startup-manufacturer 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 startup-manufacturer ISO 13485 implementation.\u003c\/li\u003e\n\u003cli\u003eSupport EU MDR technical documentation or quality-system reviews where startup-manufacturer ISO 13485 implementation records need to be complete, controlled, and consistent.\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eUse this startup-manufacturer edition to define your operating model early, prioritize evidence that will actually be sampled, and reduce wasted implementation effort.\u003c\/p\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":46615778853058,"sku":"ISO 13485 QMS-in-a-Box — Startup Manufacturer (Class I–IIa)","price":499.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_GeminiFlash_Createasquarepremiumproductthumbnailfor_ISO13485QMS-in-a-Box-StartupManufa74305.png?v=1773430939"},{"product_id":"iso-13485-qms-in-a-box-virtual-manufacturer","title":"ISO 13485 QMS-in-a-Box — Virtual Manufacturer \/ Outsourced Production","description":"\u003cp\u003eVirtual manufacturers often assume outsourcing reduces QMS burden, but audits focus heavily on how the legal manufacturer controls suppliers, release, and non-transferable responsibilities. This virtual-manufacturer edition hard-locks outsourced-process oversight, supplier control, and release responsibility so you can demonstrate control even when production is external. 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 Virtual manufacturer, Quality manager, Supply chain lead, 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 virtual-manufacturer 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 virtual-manufacturer ISO 13485 implementation.\u003c\/li\u003e\n\u003cli\u003eSupport EU MDR technical documentation or quality-system reviews where virtual-manufacturer ISO 13485 implementation records need to be complete, controlled, and consistent.\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eUse this virtual-manufacturer edition to tighten supplier oversight, clarify release authority, and show auditors that outsourced production remains under effective manufacturer control.\u003c\/p\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":46615893508290,"sku":"ISO 13485 QMS-in-a-Box — Virtual Manufacturer \/ Outsourced Production","price":499.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_Createasquarepremiumproductthumbnailfor_ISO13485QMS-in-a-Box-VirtualManufa74305.png?v=1773431006"},{"product_id":"iso-13485-qms-in-a-box-distributor-importer","title":"ISO 13485 QMS-in-a-Box — Distributor \/ Importer","description":"\u003cp data-start=\"3608\" data-end=\"3834\"\u003eRole-scoped ISO 13485 system for distributors and importers. 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This system gives you the complete operating structure for clause 7.3, including templates, execution logic, traceability, and audit-defence support for real design-control implementation. 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