Faculty: Charles H. Paul | Code: MD3768
Medical device submissions—whether 510(k), PMA, or EU MDR Technical Documentation—are highly structured, deadline-driven efforts that require precise coordination across regulatory, clinical, quality, engineering, and manufacturing functions. Despite this, many organizations still rely on informal scheduling methods, disconnected spreadsheets, or static timelines that fail under real project conditions.
Unlike traditional product development projects, submission timelines are heavily influenced by regulatory dependencies, review cycles, document readiness, and cross-functional inputs that are often outside direct project control. Delays in one area—such as verification testing, risk management documentation, or clinical data—can cascade across the entire submission timeline. Effective project scheduling in this environment is not just about sequencing tasks—it is about managing interdependencies, anticipating bottlenecks, aligning stakeholder inputs, and maintaining schedule integrity under regulatory pressure.
This webinar focuses on practical, real-world scheduling techniques specifically tailored to medical device submissions, providing participants with tools to build, manage, and control timelines that hold up under actual submission conditions.
Most medical device submission delays are not caused by technical failure—they are caused by poor scheduling discipline. Organizations often believe they have a “timeline,” but in reality, they have a list of dates without true dependency logic, risk visibility, or resource alignment. This creates a false sense of control. When critical activities slip—such as design verification, labeling development, or document approvals—the entire submission timeline becomes reactive instead of managed. Regulatory submissions introduce unique scheduling challenges that standard project management approaches do not fully address. These include iterative document development, regulatory feedback loops, parallel workstreams, and cross-functional dependencies that are difficult to track without a structured scheduling approach.
Without a robust scheduling framework:
The result is missed deadlines, increased regulatory risk, and inefficient use of resources.
This session will provide a structured approach to building and managing submission schedules that reflect how work actually occurs in medical device environments. You will learn how to move beyond static timelines and develop dynamic, dependency-driven schedules that improve predictability and execution. If you are responsible for managing or contributing to medical device submissions, this webinar will give you practical tools to improve schedule reliability, enhance cross-functional coordination, and reduce the risk of delays.
Project scheduling for medical device submissions is fundamentally different from traditional project scheduling. While standard project management focuses on task sequencing and duration estimation, submission scheduling must account for regulatory expectations, document interdependencies, iterative review cycles, and cross-functional coordination. This webinar introduces a structured approach to building submission schedules that are both realistic and executable. Participants will learn how to define and decompose submission activities into manageable components, ensuring alignment between technical work, documentation development, and regulatory requirements.
The session begins with an overview of the unique challenges associated with scheduling medical device submissions, including the impact of regulatory pathways (510(k), PMA, EU MDR), the role of design controls, and the importance of aligning scheduling with documentation readiness. From there, the webinar explores practical techniques for developing a Work Breakdown Structure (WBS) tailored to submission activities. This includes breaking down complex deliverables such as Design History Files, Risk Management Files, Clinical Evaluation Reports, and Technical Documentation into discrete, schedulable components.
Participants will then learn how to establish logical dependencies between tasks, moving beyond simple date-based planning to a dependency-driven scheduling model. This includes identifying predecessor and successor relationships, understanding parallel versus sequential workstreams, and managing cross-functional inputs. A key focus of the session is identifying and managing the critical path—the sequence of activities that directly determines the submission timeline. Attendees will learn how to recognize critical path activities, monitor schedule performance, and implement controls to prevent delays. The webinar also addresses resource considerations, including how to account for limited SME availability, competing priorities, and review/approval bottlenecks that commonly impact submission timelines.
In addition, participants will explore techniques for managing schedule risk, including contingency planning, buffer management, and proactive identification of potential delays. Finally, the session covers practical tools and approaches for maintaining schedule visibility and control throughout the submission process, including the use of scheduling software, status tracking methods, and communication strategies that keep stakeholders aligned. By the end of this webinar, participants will have a clear understanding of how to build, manage, and control submission schedules that reflect real-world conditions and support successful regulatory outcomes.
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, manufacturing, training, and technical documentation consulting firm - celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues. He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military. He has dedicated his entire professional career explaining the benefits of performance-based training