Introduction to MDR (Medical Device Regulation) compliant QMS Training by Tonex
This comprehensive training course, “Introduction to MDR (Medical Device Regulation) Compliant QMS,” offered by Tonex, equips participants with the knowledge and skills needed to navigate the evolving landscape of medical device regulations. Covering essential aspects of Quality Management Systems (QMS) compliance with the latest MDR requirements, this course is designed to empower professionals in the medical device industry.
Tonex presents an indispensable “Introduction to MDR (Medical Device Regulation) Compliant QMS” training, meticulously crafted to empower professionals in the dynamic medical device industry. This comprehensive course navigates through the intricacies of the latest MDR standards, equipping participants with the knowledge and practical skills required for establishing and maintaining a robust Quality Management System (QMS).
Participants will gain insights into the regulatory landscape, documentation requirements, and risk management strategies, ensuring a thorough understanding of MDR’s impact on QMS. With Tonex’s expertise, this training fosters competence in designing, implementing, and auditing MDR-compliant QMS, fostering compliance excellence in the ever-evolving regulatory environment.
Learning Objectives:
- Understand the key components of Medical Device Regulation (MDR) and its impact on QMS.
- Gain insights into designing and implementing a QMS compliant with MDR standards.
- Navigate the documentation and reporting requirements outlined in MDR.
- Learn best practices for quality assurance and risk management within a MDR-compliant QMS.
- Acquire skills in conducting effective audits to ensure ongoing compliance.
- Stay abreast of updates and changes in MDR to adapt QMS strategies accordingly.
Audience: This course is ideal for regulatory affairs professionals, quality assurance managers, compliance officers, and anyone involved in the design, manufacturing, or distribution of medical devices. It is tailored for individuals seeking a comprehensive understanding of MDR-compliant QMS and its practical application in the medical device industry.
Course Outline:
Module 1: Overview of Medical Device Regulation (MDR)
- Introduction to MDR
- Regulatory Landscape in the Medical Device Industry
- Key Changes and Updates in MDR
- Impact of MDR on the Global Market
- Compliance Challenges and Opportunities
- Case Studies and Practical Examples
Module 2: QMS Fundamentals
- Basics of Quality Management Systems
- Alignment of QMS with MDR Requirements
- Role of QMS in Ensuring Product Quality
- Documentation and Record-Keeping Standards
- Continuous Improvement Strategies
- Integration of QMS into Business Processes
Module 3: MDR Documentation Requirements
- Documentation Framework under MDR
- Technical Documentation Essentials
- Labeling and Packaging Requirements
- Post-Market Surveillance Documentation
- Record-Keeping for Traceability
- Ensuring Consistency and Accuracy in Documentation
Module 4: Implementing MDR-Compliant QMS
- Designing a MDR-Compliant QMS
- Stakeholder Engagement and Communication
- Training Programs for MDR Compliance
- Monitoring and Measurement of QMS Performance
- Corrective and Preventive Action (CAPA) Implementation
- Adapting QMS to Changes in MDR Regulations
Module 5: Quality Assurance and Risk Management
- Principles of Quality Assurance in Medical Devices
- Risk Management Processes and Methodologies
- Identifying and Assessing Risks in QMS
- Mitigation Strategies for Quality and Compliance
- Monitoring and Controlling Risks
- Integration of Risk Management into QMS Processes
Module 6: MDR Audits and Compliance Monitoring
- Planning and Preparation for MDR Audits
- Conducting Internal Audits for QMS Compliance
- Responding to Findings and Non-Conformities
- Supplier Audits and External Assessments
- Ongoing Compliance Monitoring Strategies
- Adapting to Regulatory Changes through Audits