What you'll learn
ISO 13485 Understanding: Gain deep knowledge of ISO 13485 for the medical industry, covering normative references, definitions, and quality management.
Quality Assurance Implementation: Acquire practical skills for implementing quality assurance in medical device manufacturing, ensuring ISO 13485 compliance.
Documentation for Compliance: Learn to create essential ISO 13485 documentation, ensuring compliance through policies, objectives, manuals, procedures, and more
Comprehensive Quality Audits: Master comprehensive quality audits, including matrix tracking and full audits, preparing for ISO 13485 standards alignment.
Requirements
This course is designed to accommodate learners of all levels, including beginners. There are no specific prerequisites or requirements to enroll. However, having a basic understanding of quality assurance concepts and familiarity with the medical device industry would be beneficial. If you are new to these topics, worry not- the course starts from the fundamentals and progresses to advanced concepts, ensuring a comprehensive learning experience for all participants. No specialized tools or equipment are necessary; a computer or device with internet access for Udemy and a willingness to learn are all you need to embark on this ISO 13485 quality assurance journey.
Description
Welcome to "The Complete ISO 13485 Quality Assurance Course for Medical Devices" - your definitive guide to mastering the intricacies of quality assurance in the dynamic field of medical devices!In this comprehensive course, you will embark on a journey from the fundamental principles to advanced practical applications of ISO 13485, specifically tailored for the medical industry. Whether you're a seasoned professional or new to the field, this course is designed to cater to all levels of expertise.Key Highlights:In-Depth Standard Understanding:Gain a profound understanding of ISO 13485, covering normative references, definitions, and critical quality management principles that form the backbone of medical device quality assurance.Practical Implementation Techniques:Acquire practical skills to implement quality assurance in medical device manufacturing. Learn how to ensure compliance with ISO 13485 through structured management, streamlined procedures, and accountability.Effective Documentation and Compliance:Navigate the art of creating essential ISO 13485 documentation, including policies, objectives, manuals, procedures, work instructions, and record-keeping. Ensure effective compliance with industry standards.Thorough Quality System Audits:Master the techniques of conducting comprehensive quality system audits! Covering matrix tracking, full audits, and management reviews, you'll be well-prepared for ISO 13485 standards alignment and industry audits!By the end of this course, you'll not only have a solid theoretical understanding of ISO 13485 but also possess the practical skills needed to implement quality assurance effectively in the challenging landscape of medical device manufacturing. Join us on this educational journey and elevate your expertise in ISO 13485 Quality Assurance!
Overview
Section 1: Introduction
Lecture 1 Scope
Lecture 2 APPLICATION
Section 2: Terms and Definitions
Lecture 3 Terms and Definitions
Section 3: Quality Management System
Lecture 4 GENERAL REQUIREMENTS
Lecture 5 DOCUMENTATION REQUIREMENTS
Lecture 6 QUALITY MANUAL
Lecture 7 CONTROL OF DOCUMENTS
Lecture 8 CONTROL OF RECORDS
Section 4: Management Responsibility
Lecture 9 MANAGEMENT COMMITMENT REQUIREMENTS
Lecture 10 CUSTOMER FOCUS
Lecture 11 QUALITY POLICY
Lecture 12 PLANNING
Lecture 13 RESPONSIBILITY, AUTHORITY, AND COMMUNICATION
Lecture 14 MANAGEMENT REPRESENTATIVE
Lecture 15 INTERNAL COMMUNICATION
Lecture 16 MANAGEMENT REVIEW
Lecture 17 REVIEW INPUT
Lecture 18 REVIEW OUTPUT
Section 5: Resource Management
Lecture 19 PROVISION OF RESOURCES
Lecture 20 HUMAN RESOURCE
Lecture 21 COMPETENCE, AWARENESS, AND TRAINING
Lecture 22 INFRASTRUCTURE
Lecture 23 WORK ENVIRONMENT
Lecture 24 Human Resources Health
Section 6: Product Realization
Lecture 25 PLANNING OF PRODUCT REALIZATION
Lecture 26 VERIFICATION OF PRODUCT
Lecture 27 CUSTOMER-RELATED PROCESSES
Lecture 28 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT REQUIREMENTS
Lecture 29 CUSTOMER COMMUNICATION
Lecture 30 DESIGN AND DEVELOPMENT
Lecture 31 DESIGN AND DEVELOPMENT INPUTS
Lecture 32 DESIGN AND DEVELOPMENT OUTPUTS
Lecture 33 DESIGN AND DEVELOPMENT REVIEW
Lecture 34 VERIFICATION REQUIREMENTS
Lecture 35 DESIGN AND DEVELOPMENT VALIDATION
Lecture 36 CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Lecture 37 PURCHASING PROCESS
Lecture 38 PURCHASING INFORMATION
Lecture 39 VERIFICATION OF PURCHASED PRODUCT
Lecture 40 PRODUCTION AND SERVICE PROVISION
Lecture 41 THE USE OF MONITORING AND MEASURING DEVICES
Lecture 42 CONTROL OF PRODUCTION AND SERVICE
Lecture 43 INSTALLATION ACTIVITIES
Lecture 44 SERVICE DATA, INFORMATION, AND REPORT
Lecture 45 PARTICULAR REQUIREMENTS FOR STERILE MEDICAL DEVICES
Section 7: MEASUREMENT, ANALYSIS, AND IMPROVEMENT
Lecture 46 MEASUREMENT, ANALYSIS, AND IMPROVEMENT-GENERAL
Lecture 47 MONITORING AND MEASUREMENT
Lecture 48 INTERNAL AUDIT
Quality Assurance Professionals: Quality assurance engineers, managers, and practitioners working in the medical device sector seeking a comprehensive understanding of ISO 13485 standards and their practical implementation.,Medical Device Professionals: Professionals involved in the design, development, production, and delivery of medical devices, aiming to enhance their skills and ensure compliance with stringent industry standards.,Regulatory Affairs Specialists: Individuals responsible for navigating regulatory requirements in the medical device field, looking to deepen their knowledge of ISO 13485 for effective compliance.,Manufacturing and Process Engineers: Engineers involved in the manufacturing and process aspects of medical devices, aspiring to align their practices with ISO 13485 standards for enhanced quality assurance.,Quality Management Teams: Teams responsible for establishing and maintaining quality management systems within medical device companies, seeking a detailed guide on ISO 13485 implementation.,Entrepreneurs and Startups: Entrepreneurs venturing into the medical device industry or startup founders aiming to develop products in compliance with ISO 13485 standards for competitive advantage.,Students and Aspiring Professionals: Students and individuals entering the field of medical device quality assurance, eager to gain foundational knowledge and practical skills to kickstart their careers.



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