{"product_id":"iso-13485-requirements-and-implementation","title":"ISO 13485: Requirements and Implementation","description":"\u003cp class=\"MsoNormal\"\u003e\u003cspan style=\"color: rgb(0, 194, 203);\"\u003e\u003cstrong\u003e20% discount for Registration of 2 or more participants. \u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003eCourse Overview\u003c\/b\u003e\u003cbr\u003eThis interactive online course is designed for the professionals who need to understand, implement and maintain ISO 13485:2016, the international standard for Quality Management Systems in medical device industry. Delivered live by a high experienced trainer, the course combines presentations, real-world case studies, practical workshops, and Q\u0026amp;A sessions to ensure participants gain both knowledge and hands-on experience.\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003eWhat You Will Learn\u003c\/b\u003e\u003c\/p\u003e\n\u003cul style=\"margin-top: 0cm;\" type=\"disc\"\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l1 level1 lfo1; tab-stops: list 36.0pt;\"\u003eKey requirements of ISO 13485:2016 and how they implement in your organization\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l1 level1 lfo1; tab-stops: list 36.0pt;\"\u003ePractical steps for implementing and maintaining a compliant QMS\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l1 level1 lfo1; tab-stops: list 36.0pt;\"\u003eIntegration of risk management and applicable regulatory requirements (EU MDR, FDA, TGA, etc.)\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l1 level1 lfo1; tab-stops: list 36.0pt;\"\u003eDocumentation structure and best practices for efficiency and compliance\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l1 level1 lfo1; tab-stops: list 36.0pt;\"\u003eHow to prepare for audits and avoid common nonconformities\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003eInteractive Features\u003c\/b\u003e\u003c\/p\u003e\n\u003cul style=\"margin-top: 0cm;\" type=\"disc\"\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l1 level1 lfo1; tab-stops: list 36.0pt;\"\u003e\n\u003cb\u003eWorkshops:\u003c\/b\u003e Practical exercises to apply ISO 13485 requirements to real scenarios\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l1 level1 lfo1; tab-stops: list 36.0pt;\"\u003e\n\u003cb\u003eQ\u0026amp;A Sessions:\u003c\/b\u003e Dedicated time to discuss participant questions and specific challenges\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l1 level1 lfo1; tab-stops: list 36.0pt;\"\u003e\n\u003cb\u003eLive Discussions:\u003c\/b\u003e Opportunities to share experiences and learn from peers\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003eWho Should Attend\u003c\/b\u003e\u003c\/p\u003e\n\u003cul style=\"margin-top: 0cm;\" type=\"disc\"\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l0 level1 lfo2; tab-stops: list 36.0pt;\"\u003eQA\/RA professionals in medical devices\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l0 level1 lfo2; tab-stops: list 36.0pt;\"\u003eManufacturers, suppliers, and startups entering the MedTech sector\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l0 level1 lfo2; tab-stops: list 36.0pt;\"\u003eConsultants, auditors, and project managers\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003eCourse Benefits\u003c\/b\u003e\u003c\/p\u003e\n\u003cul style=\"margin-top: 0cm;\" type=\"disc\"\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l2 level1 lfo3; tab-stops: list 36.0pt;\"\u003eLive, interactive learning with industry insights\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l2 level1 lfo3; tab-stops: list 36.0pt;\"\u003ePractical tools and templates you can use immediately\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"mso-list: l2 level1 lfo3; tab-stops: list 36.0pt;\"\u003eCertificate of Completion\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003eFormat:\u003c\/b\u003e Live online sessions with workshops and Q\u0026amp;A\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003eDuration:\u003c\/b\u003e 2 Days (16 hours) \u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003eDates of Training course:\u003c\/b\u003e 27th \u0026amp; 28th Nov. 2025\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003eTrainer:\u003c\/b\u003e Hasan Zarin Mehr, with over 18 years of experience in the medical device industry, has served as a Principal Consultant and worked with Notified Bodies as a Lead Auditor and Technical Documentation Assessor for standards and regulations including ISO 13485, MDSAP, EU MDR, UKCA, and more.\u003cbr data-is-only-node=\"\" data-end=\"432\" data-start=\"429\"\u003eWith a background in Biomedical Engineering, he brings deep practical expertise, delivering training that combines real-world scenarios with actionable, experience-based solutions.\u003c\/p\u003e\n\u003ch3 class=\"MsoNormal\"\u003e\n\u003cstrong\u003e\u003c\/strong\u003e\u003cbr\u003e\n\u003c\/h3\u003e","brand":"Documedex","offers":[{"title":"Default Title","offer_id":41008103784506,"sku":null,"price":590.0,"currency_code":"AUD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0566\/2765\/8810\/files\/stethoscope-scrubs.jpg?v=1726801689","url":"https:\/\/documedex.com.au\/products\/iso-13485-requirements-and-implementation","provider":"Documedex","version":"1.0","type":"link"}