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Mastering Medical Device Development; A Step-by-Step Guide to Bringing Innovative Products to Market

Mastering Medical Device Development; A Step-by-Step Guide to Bringing Innovative Products to Market

$199.00
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Mastering Medical Device Development: A Step-by-Step Guide to Bringing Innovative Products to Market

Upon completion of this comprehensive course, participants will receive a certificate issued by The Art of Service, demonstrating their expertise in medical device development.



Course Overview

This interactive and engaging course provides a step-by-step guide to bringing innovative medical devices to market. With a comprehensive and personalized approach, participants will gain practical knowledge and real-world insights into the medical device development process.



Course Features

  • Interactive and engaging content
  • Comprehensive and personalized learning experience
  • Up-to-date and high-quality content
  • Expert instructors with industry experience
  • Certificate issued by The Art of Service upon completion
  • Flexible learning schedule and user-friendly interface
  • Mobile-accessible and community-driven
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking features


Course Outline

Module 1: Introduction to Medical Device Development

  • Overview of the medical device industry
  • Types of medical devices and their applications
  • Regulatory frameworks and standards
  • Product development lifecycle

Module 2: Design and Development

  • Design principles and methodologies
  • Human factors engineering and usability
  • Material selection and biocompatibility
  • Design for manufacturability and assembly

Module 3: Testing and Validation

  • Types of testing and validation methods
  • Design of experiments and statistical analysis
  • Clinical trials and human subject testing
  • Test method validation and equipment qualification

Module 4: Regulatory Affairs and Compliance

  • Overview of regulatory agencies and standards
  • 510(k) and PMA submissions
  • ISO 13485 and FDA QSR compliance
  • Post-market surveillance and vigilance

Module 5: Manufacturing and Quality Systems

  • Manufacturing processes and technologies
  • Quality management systems and ISO 13485
  • Supply chain management and logistics
  • Process validation and control

Module 6: Marketing and Sales

  • Market research and analysis
  • Product positioning and branding
  • Sales strategies and tactics
  • Reimbursement and pricing strategies

Module 7: Post-Market Activities

  • Post-market surveillance and vigilance
  • Adverse event reporting and complaint handling
  • Corrective and preventive actions (CAPA)
  • Product recall and field correction

Module 8: Emerging Trends and Technologies

  • Overview of emerging trends and technologies
  • Artificial intelligence and machine learning
  • Internet of Things (IoT) and connected devices
  • 3D printing and additive manufacturing

Module 9: Final Project and Course Wrap-Up

  • Final project presentation and feedback
  • Course review and summary
  • Next steps and future directions
Upon completion of this comprehensive course, participants will receive a certificate issued by The Art of Service, demonstrating their expertise in medical device development.

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