{"product_id":"iso-13485-complete-training-track","title":"ISO 13485:2016 Complete Training Track (3 Courses, 3 Certificates)","description":"\u003cp\u003e\u003cstrong\u003eAll three ISO 13485:2016 courses in one purchase: Foundations, Internal Auditor and Lead Implementer.\u003c\/strong\u003e About 18 hours of video and about 46 learning hours of medical device quality management training, with a Certificate of Completion for each course. Bought separately they cost $797; this ISO 13485 training bundle saves you 25%.\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFormat:\u003c\/strong\u003e three online, self-paced courses, any device\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAccess:\u003c\/strong\u003e unlimited access to all three courses, granted the moment your order is paid\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAssessment:\u003c\/strong\u003e knowledge checks after every lesson (100% to continue), module quizzes and an open-book final exam per course\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCertificates:\u003c\/strong\u003e three Certificates of Completion, one per course\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eWhat you get\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003e\n\u003ca href=\"\/products\/iso-13485-foundations-course\"\u003e\u003cstrong\u003eISO 13485:2016 Foundations\u003c\/strong\u003e\u003c\/a\u003e: every clause in plain English, the vocabulary, the roles, and how 13485 differs from 9001.\u003c\/li\u003e\n\u003cli\u003e\n\u003ca href=\"\/products\/iso-13485-internal-auditor-course\"\u003e\u003cstrong\u003eISO 13485:2016 Internal Auditor\u003c\/strong\u003e\u003c\/a\u003e: the audit cycle, clause 8.2.4, special processes, role-plays, a full mock audit of a catheter manufacturer with evidence pack and templates.\u003c\/li\u003e\n\u003cli\u003e\n\u003ca href=\"\/products\/iso-13485-lead-implementer-course\"\u003e\u003cstrong\u003eISO 13485:2016 Lead Implementer\u003c\/strong\u003e\u003c\/a\u003e: the 30-week implementation roadmap, every required procedure and record, the medical device file and design file in practice, post-market design and the certification journey.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eSuggested order\u003c\/h2\u003e\u003cp\u003eFoundations, then Internal Auditor, then Lead Implementer. Experienced quality professionals can start with Internal Auditor.\u003c\/p\u003e\u003ch2\u003eWho it is for\u003c\/h2\u003e\u003cp\u003eQuality and regulatory professionals, consultants and founders who need full command of ISO 13485:2016, engineers moving into medical device quality, and device companies training a quality lead.\u003c\/p\u003e\u003ch2\u003eAbout your certificates\u003c\/h2\u003e\u003cp\u003eEach course ends with an ISO Cloud Consulting \u003cstrong\u003eCertificate of Completion\u003c\/strong\u003e. These are certificates of completion only: they are not accredited or certified qualifications and they do 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. Today they serve as documented evidence of training under ISO 13485:2016 clause 6.2.\u003c\/p\u003e\u003ch2\u003eFrequently asked questions\u003c\/h2\u003e\u003ch3\u003eWhich ISO 13485 course should I take?\u003c\/h3\u003e\u003cp\u003eNew to medical device quality: Foundations. Auditing your own or a supplier's QMS: Internal Auditor. Building or upgrading a QMS: Lead Implementer. The bundle covers all three in order.\u003c\/p\u003e\u003ch3\u003eIs ISO 13485 training worth it for a career change?\u003c\/h3\u003e\u003cp\u003eMedical device companies need people who understand ISO 13485, design controls, risk management and post-market requirements. Documented training plus a portfolio of worksheets and a capstone gives you concrete evidence to show employers.\u003c\/p\u003e\u003ch3\u003eHow long do I have access?\u003c\/h3\u003e\u003cp\u003eUnlimited access to every course in the bundle, with no expiry date.\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 any 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":67767269654722,"sku":"ICC-COURSE-MD-TRACK","price":599.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-complete-training-track.png?v=1791815690","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-complete-training-track","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}