{"product_id":"iso-13485-lead-implementer-course","title":"ISO 13485:2016 Lead Implementer Course (Online, Certificate of Completion)","description":"\u003cp\u003e\u003cstrong\u003eBuild an ISO 13485:2016 quality management system designed to pass certification and meet regulators' expectations.\u003c\/strong\u003e This practical, self-paced ISO 13485 lead implementer course gives you a 30-week roadmap, every required documented procedure and record, the medical device file and design file in practice, software validation, supplier qualification, post-market design and the certification journey. About 7 hours of video, 32 worksheets, 18 templates and a capstone (about 26 learning hours in total), quizzes, a final exam and an ISO Cloud Consulting Certificate of Completion. No PECB exam or experience prerequisite: you learn the method and leave with working documents.\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFormat:\u003c\/strong\u003e online, self-paced, any device\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAccess:\u003c\/strong\u003e unlimited access, granted the moment your order is paid\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLength:\u003c\/strong\u003e about 7 hours of video, about 26 learning hours\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAssessment:\u003c\/strong\u003e knowledge check after every lesson (100% to continue, unlimited retries), module quizzes (70%), open-book final exam with scenario questions\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCertificate:\u003c\/strong\u003e Certificate of Completion with a unique number\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eWhat does an ISO 13485 lead implementer do?\u003c\/h2\u003e\u003cp\u003eAn ISO 13485 lead implementer plans and delivers a medical device QMS: scoping, gap analysis, procedures, integration of ISO 14971 risk management, training, internal audits and management review, through to readiness for certification by a certification body, notified body or MDSAP auditing organization.\u003c\/p\u003e\u003ch2\u003eWhat you will be able to do\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003eExplain the regulatory logic of ISO 13485, define your organization's roles, and justify any exclusion and non-application correctly in the quality manual.\u003c\/li\u003e\n\u003cli\u003eRun the implementation as a project: gap analysis, charter, QMS architecture and documentation hierarchy, process mapping, a procedure-writing programme, records and file structures, software validation, supplier qualification, training, internal audit, management review and audit readiness, with RACI and budget.\u003c\/li\u003e\n\u003cli\u003eDesign and document each clause area without over-documenting, with tooling choices (paper, Microsoft 365, Google Workspace or an eQMS) and the validation implications of clause 4.1.6.\u003c\/li\u003e\n\u003cli\u003eBuild the medical device file and the design and development file, with a traceability matrix from inputs through outputs, verification and validation, linked to risk management and labelling.\u003c\/li\u003e\n\u003cli\u003eDesign the post-market system: feedback, complaints, reporting to regulatory authorities (vigilance), advisory notice and recall readiness, trend analysis.\u003c\/li\u003e\n\u003cli\u003eChoose a certification body, notified body or MDSAP auditing organization and prepare for stage 1 and stage 2.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow the course works\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eOrientation and the regulatory logic (including the relationship to ISO 14971, IEC 62366-1, ISO 11607 and IEC 62304, and global recognition at overview level).\u003c\/li\u003e\n\u003cli\u003eImplementation roadmap and project management.\u003c\/li\u003e\n\u003cli\u003eDesigning and documenting clauses 4 to 8 (six modules).\u003c\/li\u003e\n\u003cli\u003eThe medical device file and design file in practice.\u003c\/li\u003e\n\u003cli\u003ePost-market system design.\u003c\/li\u003e\n\u003cli\u003eThe certification journey.\u003c\/li\u003e\n\u003cli\u003eConsultant's toolkit: kick-off agenda, procedure style guide, quality agreement outline, training matrix, management review agenda, go-live checklist.\u003c\/li\u003e\n\u003cli\u003eCapstone: full implementation plan and gap analysis for a wound-dressing manufacturer, with model answer.\u003c\/li\u003e\n\u003cli\u003eA knowledge check after every lesson that you must pass (100%, unlimited retries), module quizzes (70%), and an open-book final exam (Paper A: 60 questions including scenario sets, 150 minutes, 75% to pass; a different Paper B is available if you need a second attempt), then your certificate.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eTemplates included\u003c\/h2\u003e\u003cp\u003eClause-by-clause gap analysis workbook, required documented procedures checklist, records list with retention rules, project charter, 30-week plan, process map template, quality manual outline, medical device file index, design and development file index, supplier risk classification matrix, software inventory and validation plan, management review agenda, certification readiness checklist.\u003c\/p\u003e\u003ch2\u003eWho it is for\u003c\/h2\u003e\u003cp\u003eQuality and regulatory managers, consultants and founders building or substantially upgrading a medical device QMS. Foundations-level knowledge recommended; the \u003ca href=\"\/products\/iso-13485-foundations-course\"\u003eISO 13485 Foundations Course\u003c\/a\u003e covers it.\u003c\/p\u003e\u003ch2\u003eAbout your certificate\u003c\/h2\u003e\u003cp\u003eYou receive an ISO Cloud Consulting \u003cstrong\u003eCertificate of Completion\u003c\/strong\u003e when you complete every lesson, pass every knowledge check and quiz, and pass the final exam. It is a certificate of completion only: it is not an accredited or certified qualification (it is not the PECB ISO 13485 Lead Implementer credential, CQI\/IRCA or Exemplar Global) and it does not certify any organisation. ISO Cloud Consulting is a new company and intends to apply for international recognition of its course certificates before the end of 2027.\u003c\/p\u003e\u003ch2\u003eFrequently asked questions\u003c\/h2\u003e\u003ch3\u003eHow long does ISO 13485 implementation take?\u003c\/h3\u003e\u003cp\u003eTypically 6 to 12 months for a small or mid-sized device company, depending on device class, design activity, existing processes and resources. The course uses a 30-week roadmap and ready templates to keep documentation time down.\u003c\/p\u003e\u003ch3\u003eLead auditor or lead implementer: what is the difference?\u003c\/h3\u003e\u003cp\u003eA lead implementer builds and runs the QMS; a lead auditor leads audits of it, usually for certification bodies or suppliers, and typically holds an accredited lead auditor qualification. Implementer training suits QA\/RA managers, consultants and founders.\u003c\/p\u003e\u003ch3\u003eDoes the FDA require ISO 13485?\u003c\/h3\u003e\u003cp\u003eSince 2 February 2026 the FDA Quality Management System Regulation (21 CFR Part 820) incorporates ISO 13485:2016 by reference, with additional FDA-specific requirements. The FDA does not issue ISO 13485 certificates, but US manufacturers must meet the QMSR, which aligns closely with ISO 13485.\u003c\/p\u003e\u003ch3\u003eHow long do I have access?\u003c\/h3\u003e\u003cp\u003eUnlimited access, with no expiry date.\u003c\/p\u003e\u003ch2\u003eRelated\u003c\/h2\u003e\u003cp\u003eSpeed up the documentation with the \u003ca href=\"\/products\/iso-13485-complete-qms-kit\"\u003eISO 13485 Complete QMS Kit\u003c\/a\u003e, the \u003ca href=\"\/products\/iso-13485-design-controls-dhf-kit\"\u003eDesign Controls \u0026amp; DHF Kit\u003c\/a\u003e and the \u003ca href=\"\/products\/iso-14971-risk-management-file-kit\"\u003eISO 14971 Risk Management File Kit\u003c\/a\u003e. Need hands-on help? See \u003ca href=\"\/pages\/iso-13485-consulting\"\u003eISO 13485 consulting\u003c\/a\u003e. Save with the \u003ca href=\"\/products\/iso-13485-complete-training-track\"\u003eISO 13485 Complete Training Track\u003c\/a\u003e (all three courses, $599).\u003c\/p\u003e\u003cp\u003e\u003cem\u003eLessons are narrated with a natural-sounding AI voice from scripts written by the instructor; slides are included as downloads. You need your own licensed copy of ISO 13485:2016. 5-day fit guarantee, before taking the final exam. Course author: \u003ca href=\"\/pages\/about-iso-cloud-consulting\"\u003eIshan Maharaj, ISO Cloud Consulting\u003c\/a\u003e.\u003c\/em\u003e\u003c\/p\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":67767267885250,"sku":"ICC-COURSE-MD-LI","price":399.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-lead-implementer-course.png?v=1791815683","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-lead-implementer-course","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}