Mastering Medical Device Single Audit Program (MDSAP): A Step-by-Step Guide to Ensure Compliance and Certification
This comprehensive course is designed to provide participants with a thorough understanding of the Medical Device Single Audit Program (MDSAP) and the skills necessary to ensure compliance and certification. Upon completion of this course, participants will receive a certificate issued by The Art of Service.Course Features: - Interactive and engaging content
- Comprehensive and personalized learning experience
- Up-to-date and practical information
- Real-world applications and case studies
- High-quality content developed by expert instructors
- Certification upon completion
- Flexible learning options
- User-friendly and mobile-accessible platform
- Community-driven discussion forums
- Actionable insights and hands-on projects
- Bite-sized lessons and lifetime access
- Gamification and progress tracking features
Course Outline: Chapter 1: Introduction to MDSAP - 1.1 What is MDSAP?
- Definition and purpose of MDSAP
- Benefits of MDSAP for medical device manufacturers
- 1.2 History and Development of MDSAP
- Background and evolution of MDSAP
- Key milestones and updates
- 1.3 MDSAP Audit Process
- Overview of the MDSAP audit process
- Audit stages and timelines
Chapter 2: MDSAP Audit Criteria and Requirements - 2.1 ISO 13485:2016 Requirements
- Overview of ISO 13485:2016 standard
- Key requirements and clauses
- 2.2 FDA 21 CFR Part 820 Requirements
- Overview of FDA 21 CFR Part 820 regulations
- Key requirements and sections
- 2.3 Additional Audit Criteria and Requirements
- Overview of additional audit criteria and requirements
- Key requirements and guidelines
Chapter 3: Preparing for an MDSAP Audit - 3.1 Pre-Audit Planning and Preparation
- Pre-audit activities and timelines
- Preparation of audit documentation and records
- 3.2 Audit Team Selection and Training
- Selection and training of audit team members
- Audit team roles and responsibilities
- 3.3 Audit Agenda and Schedule
- Preparation of audit agenda and schedule
- Audit time allocation and prioritization
Chapter 4: Conducting an MDSAP Audit - 4.1 Audit Opening and Introduction
- Audit opening and introduction procedures
- Review of audit agenda and schedule
- 4.2 Audit Fieldwork and Data Collection
- Audit fieldwork and data collection procedures
- Review of audit findings and observations
- 4.3 Audit Closing and Reporting
- Audit closing and reporting procedures
- Preparation of audit report and recommendations
Chapter 5: MDSAP Audit Follow-up and Surveillance - 5.1 Audit Follow-up and Corrective Actions
- Audit follow-up and corrective action procedures
- Review of corrective action plans and implementation
- 5.2 Surveillance and Re-audit Activities
- Surveillance and re-audit procedures
- Review of re-audit findings and recommendations
Chapter 6: MDSAP Certification and Maintenance - 6.1 MDSAP Certification Process
- Overview of MDSAP certification process
- Certification requirements and timelines
- 6.2 MDSAP Certification Maintenance
- Maintenance of MDSAP certification
- Surveillance and re-audit requirements
Chapter 7: MDSAP and Regulatory Compliance - 7.1 Regulatory Compliance and MDSAP
- Overview of regulatory compliance and MDSAP
- Key regulatory requirements and guidelines
- 7.2 FDA and MDSAP Compliance
- Overview of FDA and MDSAP compliance
- Key FDA requirements and guidelines
- 7.3 EU MDR and MDSAP Compliance
- Overview of EU MDR and MDSAP compliance
- Key EU MDR requirements and guidelines
Chapter 8: MDSAP and Quality Management Systems - 8.1 Quality Management Systems and MDSAP
- Overview of quality management systems and MDSAP
- Key quality management system requirements and guidelines
- 8.2 ISO 13485:2016 and MDSAP
- Overview of ISO 13485:2016 and MDSAP
- Key ISO 13485:2016 requirements and guidelines
- 8.3 Quality Management System Implementation and Maintenance
- Implementation and maintenance of quality management systems
- Key quality management system activities and timelines
Chapter 9: MDSAP and Risk Management - 9.1 Risk Management and MDSAP
- Overview of risk management and MDSAP
- Key risk management requirements and guidelines
- 9.2 ISO 14971:2019 and MDSAP
- Overview of ISO 14971:2019 and MDSAP
- Key ISO 14971:2019 requirements and guidelines
- 9.3 Risk Management Implementation and Maintenance
- Implementation and maintenance of risk management systems
- Key risk management activities and timelines
Chapter 10: MDSAP and Supply Chain Management - 10.1 Supply Chain Management and MDSAP
- Overview of supply chain management and MDSAP
- Key supply chain management requirements and guidelines
- 10.2 Supplier Selection and Qualification
- Supplier selection and qualification procedures
- Key supplier selection and qualification requirements
- 10.3 Supply Chain Risk Management
- Supply chain risk management procedures,
Chapter 1: Introduction to MDSAP
- 1.1 What is MDSAP?
- Definition and purpose of MDSAP
- Benefits of MDSAP for medical device manufacturers
- 1.2 History and Development of MDSAP
- Background and evolution of MDSAP
- Key milestones and updates
- 1.3 MDSAP Audit Process
- Overview of the MDSAP audit process
- Audit stages and timelines
Chapter 2: MDSAP Audit Criteria and Requirements
- 2.1 ISO 13485:2016 Requirements
- Overview of ISO 13485:2016 standard
- Key requirements and clauses
- 2.2 FDA 21 CFR Part 820 Requirements
- Overview of FDA 21 CFR Part 820 regulations
- Key requirements and sections
- 2.3 Additional Audit Criteria and Requirements
- Overview of additional audit criteria and requirements
- Key requirements and guidelines
Chapter 3: Preparing for an MDSAP Audit
- 3.1 Pre-Audit Planning and Preparation
- Pre-audit activities and timelines
- Preparation of audit documentation and records
- 3.2 Audit Team Selection and Training
- Selection and training of audit team members
- Audit team roles and responsibilities
- 3.3 Audit Agenda and Schedule
- Preparation of audit agenda and schedule
- Audit time allocation and prioritization
Chapter 4: Conducting an MDSAP Audit
- 4.1 Audit Opening and Introduction
- Audit opening and introduction procedures
- Review of audit agenda and schedule
- 4.2 Audit Fieldwork and Data Collection
- Audit fieldwork and data collection procedures
- Review of audit findings and observations
- 4.3 Audit Closing and Reporting
- Audit closing and reporting procedures
- Preparation of audit report and recommendations
Chapter 5: MDSAP Audit Follow-up and Surveillance
- 5.1 Audit Follow-up and Corrective Actions
- Audit follow-up and corrective action procedures
- Review of corrective action plans and implementation
- 5.2 Surveillance and Re-audit Activities
- Surveillance and re-audit procedures
- Review of re-audit findings and recommendations
Chapter 6: MDSAP Certification and Maintenance
- 6.1 MDSAP Certification Process
- Overview of MDSAP certification process
- Certification requirements and timelines
- 6.2 MDSAP Certification Maintenance
- Maintenance of MDSAP certification
- Surveillance and re-audit requirements
Chapter 7: MDSAP and Regulatory Compliance
- 7.1 Regulatory Compliance and MDSAP
- Overview of regulatory compliance and MDSAP
- Key regulatory requirements and guidelines
- 7.2 FDA and MDSAP Compliance
- Overview of FDA and MDSAP compliance
- Key FDA requirements and guidelines
- 7.3 EU MDR and MDSAP Compliance
- Overview of EU MDR and MDSAP compliance
- Key EU MDR requirements and guidelines
Chapter 8: MDSAP and Quality Management Systems
- 8.1 Quality Management Systems and MDSAP
- Overview of quality management systems and MDSAP
- Key quality management system requirements and guidelines
- 8.2 ISO 13485:2016 and MDSAP
- Overview of ISO 13485:2016 and MDSAP
- Key ISO 13485:2016 requirements and guidelines
- 8.3 Quality Management System Implementation and Maintenance
- Implementation and maintenance of quality management systems
- Key quality management system activities and timelines
Chapter 9: MDSAP and Risk Management
- 9.1 Risk Management and MDSAP
- Overview of risk management and MDSAP
- Key risk management requirements and guidelines
- 9.2 ISO 14971:2019 and MDSAP
- Overview of ISO 14971:2019 and MDSAP
- Key ISO 14971:2019 requirements and guidelines
- 9.3 Risk Management Implementation and Maintenance
- Implementation and maintenance of risk management systems
- Key risk management activities and timelines
Chapter 10: MDSAP and Supply Chain Management
- 10.1 Supply Chain Management and MDSAP
- Overview of supply chain management and MDSAP
- Key supply chain management requirements and guidelines
- 10.2 Supplier Selection and Qualification
- Supplier selection and qualification procedures
- Key supplier selection and qualification requirements
- 10.3 Supply Chain Risk Management
- Supply chain risk management procedures,