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Mastering Quality Management Systems (QMS) for Medical Device Software; A Step-by-Step Guide to Ensuring Compliance and Patient Safety

Mastering Quality Management Systems (QMS) for Medical Device Software; A Step-by-Step Guide to Ensuring Compliance and Patient Safety

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Mastering Quality Management Systems (QMS) for Medical Device Software: A Step-by-Step Guide to Ensuring Compliance and Patient Safety



Course Overview

This comprehensive course is designed to provide participants with a thorough understanding of Quality Management Systems (QMS) for medical device software, ensuring compliance with regulatory requirements and patient safety. Upon completion, participants will receive a certificate issued by The Art of Service.



Course Features

  • Interactive and engaging learning experience
  • Comprehensive and personalized course content
  • Up-to-date information on regulatory requirements and industry standards
  • Practical, real-world applications and case studies
  • High-quality content developed by expert instructors
  • Certificate issued by The Art of Service upon completion
  • Flexible learning options, including self-paced and instructor-led
  • User-friendly and mobile-accessible platform
  • Community-driven discussion forums and support
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access to course materials
  • Gamification and progress tracking features


Course Outline

Module 1: Introduction to QMS for Medical Device Software

  • Overview of QMS and its importance in medical device software development
  • Regulatory requirements and industry standards for QMS
  • Key components of a QMS, including policies, procedures, and records

Module 2: QMS Framework and Structure

  • ISO 13485 and ISO 9001 frameworks for QMS
  • Establishing a QMS structure, including departments and roles
  • Defining QMS policies and procedures

Module 3: Risk Management and Quality Planning

  • Risk management principles and techniques
  • Quality planning and setting quality objectives
  • Establishing a quality manual and quality procedures

Module 4: Design and Development Controls

  • Design and development process for medical device software
  • Design controls, including input, output, and verification
  • Development controls, including coding, testing, and validation

Module 5: Testing and Validation

  • Testing principles and techniques for medical device software
  • Validation principles and techniques for medical device software
  • Establishing testing and validation procedures

Module 6: Change Control and Configuration Management

  • Change control principles and techniques
  • Configuration management principles and techniques
  • Establishing change control and configuration management procedures

Module 7: Document Control and Record Keeping

  • Document control principles and techniques
  • Record keeping principles and techniques
  • Establishing document control and record keeping procedures

Module 8: Audits and Compliance

  • Audit principles and techniques for QMS
  • Compliance with regulatory requirements and industry standards
  • Establishing audit procedures and compliance programs

Module 9: Continuous Improvement and Corrective Action

  • Continuous improvement principles and techniques
  • Corrective action principles and techniques
  • Establishing continuous improvement and corrective action procedures

Module 10: QMS Implementation and Maintenance

  • Implementing a QMS in a medical device software organization
  • Maintaining a QMS, including monitoring and evaluation
  • Establishing QMS implementation and maintenance procedures


Certificate

Upon completion of the course, participants will receive a certificate issued by The Art of Service, demonstrating their mastery of Quality Management Systems (QMS) for medical device software.



Target Audience

  • Medical device software developers and manufacturers
  • Quality managers and quality engineers
  • Regulatory affairs professionals
  • Compliance officers
  • Auditors and assessors


Prerequisites

There are no prerequisites for this course. It is designed to be comprehensive and accessible to participants with varying levels of experience and knowledge.



Course Format

This course is available in self-paced and instructor-led formats, with flexible learning options to accommodate different learning styles and schedules.



Course Duration

The course duration is approximately 80 hours, with lifetime access to course materials and support.

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