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MDSAP Implementation and Self Assessment Checklist for Medical Device Manufacturers

MDSAP Implementation and Self Assessment Checklist for Medical Device Manufacturers

$199.00
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MDSAP Implementation and Self-Assessment Checklist for Medical Device Manufacturers



Course Overview

This comprehensive course is designed to equip medical device manufacturers with the knowledge and skills necessary to implement the Medical Device Single Audit Program (MDSAP) and conduct a thorough self-assessment. Upon completion, participants will receive a certificate issued by The Art of Service.



Course Objectives

  • Understand the MDSAP requirements and guidelines
  • Develop a comprehensive understanding of the MDSAP audit process
  • Learn how to conduct a self-assessment using the MDSAP checklist
  • Identify and address gaps in their quality management system
  • Implement MDSAP requirements and maintain compliance


Course Outline

Module 1: Introduction to MDSAP

  • Overview of MDSAP and its benefits
  • History and evolution of MDSAP
  • MDSAP participating countries and regulatory authorities
  • MDSAP structure and documentation

Module 2: MDSAP Requirements and Guidelines

  • MDSAP audit process and procedures
  • MDSAP checklist and its application
  • ISO 13485:2016 and its relationship to MDSAP
  • Regulatory requirements for medical device manufacturers

Module 3: MDSAP Audit Process

  • Audit planning and preparation
  • Audit execution and reporting
  • Audit follow-up and closure
  • Audit non-conformities and corrective actions

Module 4: Self-Assessment Using the MDSAP Checklist

  • Understanding the MDSAP checklist
  • Conducting a self-assessment using the MDSAP checklist
  • Identifying and addressing gaps in the quality management system
  • Developing a corrective action plan

Module 5: Implementing MDSAP Requirements

  • Developing and implementing MDSAP-compliant procedures
  • Training personnel on MDSAP requirements
  • Maintaining MDSAP compliance
  • Continuous monitoring and improvement

Module 6: MDSAP Documentation and Record-Keeping

  • MDSAP documentation requirements
  • Maintaining accurate and complete records
  • Document control and retention
  • Record-keeping best practices

Module 7: MDSAP Audit Readiness

  • Audit readiness preparation
  • Conducting internal audits
  • Identifying and addressing audit non-conformities
  • Maintaining audit readiness

Module 8: Case Studies and Group Exercises

  • Real-world examples of MDSAP implementation
  • Group exercises to reinforce learning
  • Discussion and sharing of best practices
  • Q&A and feedback


Course Features

  • Interactive: Engaging video lessons, quizzes, and assessments
  • Comprehensive: In-depth coverage of MDSAP requirements and guidelines
  • Personalized: Learn at your own pace and convenience
  • Up-to-date: Latest information and updates on MDSAP
  • Practical: Real-world examples and case studies
  • High-quality content: Developed by expert instructors
  • Certification: Receive a certificate upon completion issued by The Art of Service
  • Flexible learning: Access the course from anywhere, at any time
  • User-friendly: Easy-to-use platform and navigation
  • Mobile-accessible: Learn on-the-go
  • Community-driven: Discussion forums and support
  • Actionable insights: Practical knowledge and skills
  • Hands-on projects: Apply learning to real-world scenarios
  • Bite-sized lessons: Short, focused lessons
  • Lifetime access: Access the course materials for a lifetime
  • Gamification: Engaging and interactive learning experience
  • Progress tracking: Monitor your progress and stay on track


Expert Instructors

Our expert instructors have extensive experience in MDSAP and medical device manufacturing. They will guide you through the course and provide support and feedback throughout.



Certificate of Completion

Upon completing the course, you will receive a certificate issued by The Art of Service, a recognized leader in professional training and certification.

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