Project Scheduling Techniques for Medical Device Submissions in US and EU

Overview:

Medical device submissions in the US and EU require precise project scheduling to ensure timely regulatory approvals.

This webinar, Project Scheduling Techniques for Medical Device Submissions in US and EU, will provide participants with practical methods to develop efficient submission timelines, manage regulatory dependencies, and mitigate potential delays.

Attendees will gain insights into core scheduling techniques such as critical path analysis, Gantt charts, and risk-based planning while learning about digital tools that enhance project tracking and execution. Whether preparing a 510(k), PMA, or EU MDR/IVDR submission, this session will equip professionals with the strategies needed to streamline the process and meet regulatory deadlines effectively.

Why you should Attend:

Participants will gain essential knowledge in developing and optimizing project schedules for medical device regulatory submissions. By learning about key regulatory timelines, scheduling methodologies, and risk management strategies, attendees will be better equipped to navigate complex submission processes while minimizing delays.

This training will provide actionable techniques and tools that enable professionals to enhance efficiency, ensure compliance, and improve cross-functional coordination in regulatory project planning.

Areas Covered in the Session:

• Introduction to Project Scheduling for Regulatory Submissions (5 minutes)
  
  • Importance of structured project scheduling for medical device submissions
  • Key differences between US FDA and EU MDR/IVDR submission timelines
  • Overview of webinar objectives
• Regulatory Timelines and Submission Requirements (10 minutes)
  
  • FDA submission pathways (510(k), PMA, De Novo) and associated timelines
  • EU MDR/IVDR conformity assessment routes and notified body involvement
  • Key milestones and dependencies in the submission process
• Core Project Scheduling Techniques (10 minutes)
  
  • Gantt charts, critical path method (CPM), and PERT analysis
  • Agile vs. waterfall approaches in regulatory project management
  • Best practices for resource allocation and deadline forecasting
• Managing Risks and Delays in Regulatory Submissions (10 minutes)
  
  • Identifying common bottlenecks and regulatory hurdles
  • Contingency planning and risk-based scheduling strategies
  • Case studies of successful timeline adjustments
• Tools and Technologies for Project Scheduling (10 minutes)
  
  • Project management software (MS Project, Smartsheet, Asana, etc.)
  • Digital collaboration tools for cross-functional teams
  • Automation and AI-driven scheduling enhancements
• Case Studies and Practical Applications (10 minutes)
  
  • Real-world examples of medical device submission schedules
  • Lessons learned from delays and expedited approvals
  • Strategies for optimizing project timelines

Who Will Benefit:

• Regulatory Affairs
• Research & Development (R&D)
• Quality Assurance & Quality Control (QA/QC)
• Clinical Operations & Clinical Development
• Manufacturing & Process Development
• Supply Chain & Logistics
• Engineering & Validation
• Project Management
• Business Strategy & Market Access
• IT & Digital Transformation