<div data-id="1881" data-import-id="" data-scenario-id="" class="cht-ai col-sm-12 "><span class="ai-assist-link"><i class="ai-agent-icon" style=""></i></span><h1 id="executivesummaryroboticsurgicalplatformregulatorysubmissionstrategy"><strong>Executive Summary: Robotic Surgical Platform Regulatory Submission Strategy</strong></h1> <p>The regulatory pathway for a robotic surgical platform targeting soft tissue procedures represents a high-complexity, multi-jurisdictional submission requiring comprehensive integration of FDA IDE/PMA, MDR CE Mark, and China NMPA approvals. This advanced medical device requires sophisticated regulatory strategy encompassing bench performance testing, human factors validation, cybersecurity assessments, and comprehensive clinical evidence generation across multiple global markets.</p> <p>The strategic timeline spans 42-48 months with parallel regulatory activities optimized for advisory panel review windows. Critical success factors include early FDA pre-submission meetings, robust predicate device analysis, comprehensive design controls implementation, and sophisticated clinical validation across multiple sites. The integration of cybersecurity requirements per FDA guidance, advanced software lifecycle processes (IEC 62304), and multi-jurisdictional quality system compliance creates significant complexity requiring expert-level project coordination.</p> <p>This comprehensive WBS addresses the full spectrum of regulatory requirements from initial design controls through post-market surveillance, ensuring alignment with FDA, MDR, and NMPA standards while optimizing for competitive market entry timing.</p> <hr> <h2 id="regulatorysubmissionandapprovalplanroboticsurgicalplatform"><strong>Regulatory Submission and Approval Plan: Robotic Surgical Platform</strong></h2> <div data-id="1881" class="table-wrap"><div class="top-row"><div class="pull-right"><a href="planner/csv/1881" data-rel="tooltip" data-original-title="Download CSV" class="js-csv"><i class="fa fa-fw fa-download"></i></a></div></div><div class="table-wrap-in"><table> <thead> <tr> <th id="wbs">WBS</th> <th id="activity_name">Activity Name</th> <th id="activity_type">Activity Type</th> <th id="duration">Duration</th> <th id="start_date">Start Date</th> <th id="end_date">End Date</th> </tr> </thead> <tbody> <tr> <td>RSP</td> <td>Robotic Surgical Platform Regulatory Strategy</td> <td>Draft</td> <td></td> <td></td> <td></td> </tr> <tr> <td>1</td> <td>Pre-Submission and Strategic Planning</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>1.1</td> <td>Regulatory Strategy Development</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>1.1.1</td> <td>Device classification analysis and pathway determination</td> <td>Task</td> <td>15</td> <td>2025-01-01</td> <td>2025-01-16</td> </tr> <tr> <td>1.1.2</td> <td>Predicate device identification and substantial equivalence analysis</td> <td>Task</td> <td>21</td> <td>2025-01-17</td> <td>2025-02-07</td> </tr> <tr> <td>1.1.3</td> <td>Multi-jurisdictional regulatory gap analysis</td> <td>Task</td> <td>14</td> <td>2025-02-08</td> <td>2025-02-22</td> </tr> <tr> <td>1.1.4</td> <td>Advisory panel review calendar analysis and timeline optimization</td> <td>Task</td> <td>7</td> <td>2025-02-23</td> <td>2025-03-02</td> </tr> <tr> <td>1.1.5</td> <td>Regulatory strategy document finalization</td> <td>Milestone</td> <td>0</td> <td>2025-03-03</td> <td>2025-03-03</td> </tr> <tr> <td>1.2</td> <td>FDA Pre-Submission Activities</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>1.2.1</td> <td>Pre-submission meeting request preparation</td> <td>Task</td> <td>21</td> <td>2025-03-04</td> <td>2025-03-25</td> </tr> <tr> <td>1.2.2</td> <td>Clinical evidence requirements discussion with FDA</td> <td>Task</td> <td>14</td> <td>2025-03-26</td> <td>2025-04-09</td> </tr> <tr> <td>1.2.3</td> <td>IDE pathway requirements clarification</td> <td>Task</td> <td>10</td> <td>2025-04-10</td> <td>2025-04-20</td> </tr> <tr> <td>1.2.4</td> <td>FDA pre-submission meeting completion</td> <td>Milestone</td> <td>0</td> <td>2025-04-21</td> <td>2025-04-21</td> </tr> <tr> <td>1.3</td> <td>International Regulatory Consultation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>1.3.1</td> <td>EU Notified Body pre-assessment consultation</td> <td>Task</td> <td>28</td> <td>2025-04-22</td> <td>2025-05-20</td> </tr> <tr> <td>1.3.2</td> <td>China NMPA pathway consultation and requirements analysis</td> <td>Task</td> <td>35</td> <td>2025-05-21</td> <td>2025-06-25</td> </tr> <tr> <td>1.3.3</td> <td>International harmonization strategy development</td> <td>Task</td> <td>14</td> <td>2025-06-26</td> <td>2025-07-10</td> </tr> <tr> <td>1.3.4</td> <td>Multi-jurisdictional consultation completion</td> <td>Milestone</td> <td>0</td> <td>2025-07-11</td> <td>2025-07-11</td> </tr> <tr> <td>2</td> <td>Design Controls and Quality System Implementation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.1</td> <td>Design Control Framework Development</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.1.1</td> <td>Design input specification development</td> <td>Task</td> <td>28</td> <td>2025-07-12</td> <td>2025-08-09</td> </tr> <tr> <td>2.1.2</td> <td>Design output documentation creation</td> <td>Task</td> <td>35</td> <td>2025-08-10</td> <td>2025-09-14</td> </tr> <tr> <td>2.1.3</td> <td>Design review protocol establishment</td> <td>Task</td> <td>14</td> <td>2025-09-15</td> <td>2025-09-29</td> </tr> <tr> <td>2.1.4</td> <td>Design transfer procedures development</td> <td>Task</td> <td>21</td> <td>2025-09-30</td> <td>2025-10-21</td> </tr> <tr> <td>2.1.5</td> <td>Design control framework completion</td> <td>Milestone</td> <td>0</td> <td>2025-10-22</td> <td>2025-10-22</td> </tr> <tr> <td>2.2</td> <td>Quality System Integration</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.2.1</td> <td>ISO 13485 quality management system implementation</td> <td>Task</td> <td>42</td> <td>2025-10-23</td> <td>2025-12-04</td> </tr> <tr> <td>2.2.2</td> <td>Risk management system (ISO 14971) development</td> <td>Task</td> <td>35</td> <td>2025-12-05</td> <td>2026-01-09</td> </tr> <tr> <td>2.2.3</td> <td>Software lifecycle processes (IEC 62304) implementation</td> <td>Task</td> <td>49</td> <td>2026-01-10</td> <td>2026-02-28</td> </tr> <tr> <td>2.2.4</td> <td>Quality system validation and documentation</td> <td>Task</td> <td>28</td> <td>2026-03-01</td> <td>2026-03-29</td> </tr> <tr> <td>2.2.5</td> <td>Quality system implementation completion</td> <td>Milestone</td> <td>0</td> <td>2026-03-30</td> <td>2026-03-30</td> </tr> <tr> <td>2.3</td> <td>Cybersecurity Framework Development</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.3.1</td> <td>Cybersecurity risk assessment per FDA guidance</td> <td>Task</td> <td>21</td> <td>2026-03-31</td> <td>2026-04-21</td> </tr> <tr> <td>2.3.2</td> <td>Security architecture design and implementation</td> <td>Task</td> <td>35</td> <td>2026-04-22</td> <td>2026-05-27</td> </tr> <tr> <td>2.3.3</td> <td>Penetration testing and vulnerability assessment</td> <td>Task</td> <td>14</td> <td>2026-05-28</td> <td>2026-06-11</td> </tr> <tr> <td>2.3.4</td> <td>Cybersecurity documentation and validation</td> <td>Task</td> <td>21</td> <td>2026-06-12</td> <td>2026-07-03</td> </tr> <tr> <td>2.3.5</td> <td>Cybersecurity framework validation completion</td> <td>Milestone</td> <td>0</td> <td>2026-07-04</td> <td>2026-07-04</td> </tr> <tr> <td>3</td> <td>Verification and Validation Testing</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.1</td> <td>Bench Performance Testing</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.1.1</td> <td>Mechanical performance testing protocol development</td> <td>Task</td> <td>14</td> <td>2026-07-05</td> <td>2026-07-19</td> </tr> <tr> <td>3.1.2</td> <td>Precision and accuracy testing execution</td> <td>Task</td> <td>28</td> <td>2026-07-20</td> <td>2026-08-17</td> </tr> <tr> <td>3.1.3</td> <td>Durability and reliability testing</td> <td>Task</td> <td>42</td> <td>2026-08-18</td> <td>2026-09-29</td> </tr> <tr> <td>3.1.4</td> <td>Software performance and safety testing</td> <td>Task</td> <td>35</td> <td>2026-09-30</td> <td>2026-11-04</td> </tr> <tr> <td>3.1.5</td> <td>Electromagnetic compatibility (EMC) testing</td> <td>Task</td> <td>21</td> <td>2026-11-05</td> <td>2026-11-26</td> </tr> <tr> <td>3.1.6</td> <td>Biocompatibility testing completion</td> <td>Task</td> <td>28</td> <td>2026-11-27</td> <td>2026-12-25</td> </tr> <tr> <td>3.1.7</td> <td>Bench performance testing completion</td> <td>Milestone</td> <td>0</td> <td>2026-12-26</td> <td>2026-12-26</td> </tr> <tr> <td>3.2</td> <td>Human Factors and Usability Validation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.2.1</td> <td>Human factors engineering plan development</td> <td>Task</td> <td>21</td> <td>2026-12-27</td> <td>2027-01-17</td> </tr> <tr> <td>3.2.2</td> <td>Use environment analysis and user profile definition</td> <td>Task</td> <td>14</td> <td>2027-01-18</td> <td>2027-02-01</td> </tr> <tr> <td>3.2.3</td> <td>Formative usability studies execution</td> <td>Task</td> <td>35</td> <td>2027-02-02</td> <td>2027-03-09</td> </tr> <tr> <td>3.2.4</td> <td>User interface design optimization</td> <td>Task</td> <td>28</td> <td>2027-03-10</td> <td>2027-04-07</td> </tr> <tr> <td>3.2.5</td> <td>Summative usability validation studies</td> <td>Task</td> <td>42</td> <td>2027-04-08</td> <td>2027-05-20</td> </tr> <tr> <td>3.2.6</td> <td>Human factors validation report completion</td> <td>Task</td> <td>14</td> <td>2027-05-21</td> <td>2027-06-04</td> </tr> <tr> <td>3.2.7</td> <td>Human factors validation completion</td> <td>Milestone</td> <td>0</td> <td>2027-06-05</td> <td>2027-06-05</td> </tr> <tr> <td>3.3</td> <td>Clinical Performance Validation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.3.1</td> <td>Clinical investigation plan development</td> <td>Task</td> <td>28</td> <td>2027-06-06</td> <td>2027-07-04</td> </tr> <tr> <td>3.3.2</td> <td>Clinical site selection and contracting</td> <td>Task</td> <td>42</td> <td>2027-07-05</td> <td>2027-08-16</td> </tr> <tr> <td>3.3.3</td> <td>IRB/Ethics committee approvals</td> <td>Task</td> <td>35</td> <td>2027-08-17</td> <td>2027-09-21</td> </tr> <tr> <td>3.3.4</td> <td>Clinical investigation execution</td> <td>Task</td> <td>126</td> <td>2027-09-22</td> <td>2028-01-26</td> </tr> <tr> <td>3.3.5</td> <td>Clinical data analysis and statistical evaluation</td> <td>Task</td> <td>28</td> <td>2028-01-27</td> <td>2028-02-24</td> </tr> <tr> <td>3.3.6</td> <td>Clinical study report completion</td> <td>Task</td> <td>21</td> <td>2028-02-25</td> <td>2028-03-18</td> </tr> <tr> <td>3.3.7</td> <td>Clinical validation completion</td> <td>Milestone</td> <td>0</td> <td>2028-03-19</td> <td>2028-03-19</td> </tr> <tr> <td>4</td> <td>Regulatory Dossier Preparation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.1</td> <td>FDA PMA Dossier Development</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.1.1</td> <td>PMA summary and clinical data compilation</td> <td>Task</td> <td>35</td> <td>2028-03-20</td> <td>2028-04-24</td> </tr> <tr> <td>4.1.2</td> <td>Non-clinical testing data integration</td> <td>Task</td> <td>21</td> <td>2028-04-25</td> <td>2028-05-16</td> </tr> <tr> <td>4.1.3</td> <td>Manufacturing information and quality data</td> <td>Task</td> <td>28</td> <td>2028-05-17</td> <td>2028-06-14</td> </tr> <tr> <td>4.1.4</td> <td>Risk analysis and benefit-risk assessment</td> <td>Task</td> <td>14</td> <td>2028-06-15</td> <td>2028-06-29</td> </tr> <tr> <td>4.1.5</td> <td>PMA dossier quality review and finalization</td> <td>Task</td> <td>21</td> <td>2028-06-30</td> <td>2028-07-21</td> </tr> <tr> <td>4.1.6</td> <td>FDA PMA dossier completion</td> <td>Milestone</td> <td>0</td> <td>2028-07-22</td> <td>2028-07-22</td> </tr> <tr> <td>4.2</td> <td>EU MDR Technical Documentation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.2.1</td> <td>MDR Annex II technical documentation compilation</td> <td>Task</td> <td>42</td> <td>2028-07-23</td> <td>2028-09-03</td> </tr> <tr> <td>4.2.2</td> <td>Clinical evaluation report development</td> <td>Task</td> <td>28</td> <td>2028-09-04</td> <td>2028-10-02</td> </tr> <tr> <td>4.2.3</td> <td>Post-market clinical follow-up plan</td> <td>Task</td> <td>14</td> <td>2028-10-03</td> <td>2028-10-17</td> </tr> <tr> <td>4.2.4</td> <td>EUDAMED registration preparation</td> <td>Task</td> <td>7</td> <td>2028-10-18</td> <td>2028-10-25</td> </tr> <tr> <td>4.2.5</td> <td>EU MDR documentation completion</td> <td>Milestone</td> <td>0</td> <td>2028-10-26</td> <td>2028-10-26</td> </tr> <tr> <td>4.3</td> <td>China NMPA Submission Package</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.3.1</td> <td>NMPA technical requirements assessment</td> <td>Task</td> <td>21</td> <td>2028-10-27</td> <td>2028-11-17</td> </tr> <tr> <td>4.3.2</td> <td>Chinese clinical data requirements compilation</td> <td>Task</td> <td>28</td> <td>2028-11-18</td> <td>2028-12-16</td> </tr> <tr> <td>4.3.3</td> <td>Manufacturing site inspection preparation</td> <td>Task</td> <td>14</td> <td>2028-12-17</td> <td>2028-12-31</td> </tr> <tr> <td>4.3.4</td> <td>NMPA submission documentation finalization</td> <td>Task</td> <td>21</td> <td>2029-01-01</td> <td>2029-01-22</td> </tr> <tr> <td>4.3.5</td> <td>China NMPA dossier completion</td> <td>Milestone</td> <td>0</td> <td>2029-01-23</td> <td>2029-01-23</td> </tr> <tr> <td>5</td> <td>Regulatory Submissions and Review Management</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.1</td> <td>FDA Submission Process</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.1.1</td> <td>IDE submission and FDA acceptance</td> <td>Task</td> <td>30</td> <td>2029-01-24</td> <td>2029-02-23</td> </tr> <tr> <td>5.1.2</td> <td>Clinical investigation under IDE</td> <td>Task</td> <td>126</td> <td>2029-02-24</td> <td>2029-06-30</td> </tr> <tr> <td>5.1.3</td> <td>PMA submission to FDA</td> <td>Task</td> <td>7</td> <td>2029-07-01</td> <td>2029-07-08</td> </tr> <tr> <td>5.1.4</td> <td>FDA administrative review and acceptance</td> <td>Task</td> <td>45</td> <td>2029-07-09</td> <td>2029-08-23</td> </tr> <tr> <td>5.1.5</td> <td>FDA substantive review response management</td> <td>Task</td> <td>90</td> <td>2029-08-24</td> <td>2029-11-22</td> </tr> <tr> <td>5.1.6</td> <td>Advisory panel preparation and presentation</td> <td>Task</td> <td>30</td> <td>2029-11-23</td> <td>2029-12-23</td> </tr> <tr> <td>5.1.7</td> <td>FDA final review and approval decision</td> <td>Decision</td> <td>60</td> <td>2029-12-24</td> <td>2030-02-22</td> </tr> <tr> <td>5.2</td> <td>EU MDR Certification Process</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.2.1</td> <td>Notified Body application submission</td> <td>Task</td> <td>7</td> <td>2029-01-24</td> <td>2029-01-31</td> </tr> <tr> <td>5.2.2</td> <td>Notified Body conformity assessment</td> <td>Task</td> <td>90</td> <td>2029-02-01</td> <td>2029-05-02</td> </tr> <tr> <td>5.2.3</td> <td>Manufacturing site audit preparation</td> <td>Task</td> <td>21</td> <td>2029-05-03</td> <td>2029-05-24</td> </tr> <tr> <td>5.2.4</td> <td>On-site audit and assessment</td> <td>Task</td> <td>5</td> <td>2029-05-25</td> <td>2029-05-30</td> </tr> <tr> <td>5.2.5</td> <td>Corrective action response and implementation</td> <td>Task</td> <td>30</td> <td>2029-05-31</td> <td>2029-06-30</td> </tr> <tr> <td>5.2.6</td> <td>CE marking certificate issuance</td> <td>Decision</td> <td>14</td> <td>2029-07-01</td> <td>2029-07-15</td> </tr> <tr> <td>5.3</td> <td>China NMPA Review Process</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.3.1</td> <td>NMPA application submission</td> <td>Task</td> <td>7</td> <td>2029-01-24</td> <td>2029-01-31</td> </tr> <tr> <td>5.3.2</td> <td>Technical review and assessment</td> <td>Task</td> <td>120</td> <td>2029-02-01</td> <td>2029-06-01</td> </tr> <tr> <td>5.3.3</td> <td>Manufacturing site inspection scheduling</td> <td>Task</td> <td>14</td> <td>2029-06-02</td> <td>2029-06-16</td> </tr> <tr> <td>5.3.4</td> <td>NMPA on-site inspection execution</td> <td>Task</td> <td>7</td> <td>2029-06-17</td> <td>2029-06-24</td> </tr> <tr> <td>5.3.5</td> <td>Inspection response and compliance demonstration</td> <td>Task</td> <td>30</td> <td>2029-06-25</td> <td>2029-07-25</td> </tr> <tr> <td>5.3.6</td> <td>NMPA final approval decision</td> <td>Decision</td> <td>60</td> <td>2029-07-26</td> <td>2029-09-24</td> </tr> </tbody> </table></div><div class="bottom-row"><div class="pull-right"><a href="planner/csv/1881" data-placement="bottom" data-rel="tooltip" data-original-title="Download CSV" class="js-csv"><i class="fa fa-fw fa-download"></i></a></div></div></div> <hr> <h2 id="comprehensiveimplementationnotes"><strong>Comprehensive Implementation Notes</strong></h2> <h3 id="regulatorystrategyexcellenceframework"><strong>Regulatory Strategy Excellence Framework:</strong></h3> <ul> <li><strong>Multi-jurisdictional alignment</strong> ensures parallel submission processes with optimized timelines and reduced regulatory risk across FDA, MDR, and NMPA pathways</li> <li><strong>Advisory panel timing optimization</strong> leverages FDA advisory committee calendars for strategic submission timing and competitive advantage</li> <li><strong>Predicate device strategy</strong> establishes substantial equivalence foundation while demonstrating innovative advancement in robotic surgical capabilities</li> </ul> <h3 id="qualitysystemintegrationrequirements"><strong>Quality System Integration Requirements:</strong></h3> <ul> <li><strong>ISO 13485 implementation</strong> with specific focus on design controls, risk management, and software lifecycle processes for robotic surgical platforms</li> <li><strong>Cybersecurity framework compliance</strong> per FDA cybersecurity guidance with comprehensive threat modeling and security architecture validation</li> <li><strong>Software validation excellence</strong> following IEC 62304 standards with particular attention to safety-critical software functions and failure mode analysis</li> </ul> <h3 id="clinicalandhumanfactorsvalidation"><strong>Clinical and Human Factors Validation:</strong></h3> <ul> <li><strong>Multi-site clinical investigation</strong> designed to demonstrate safety and effectiveness across diverse surgical environments and user populations</li> <li><strong>Human factors engineering</strong> with comprehensive use environment analysis, formative and summative usability studies, and user interface optimization</li> <li><strong>Real-world evidence integration</strong> preparing for post-market surveillance and continued clinical data collection requirements</li> </ul> <h3 id="submissiontimelineoptimization"><strong>Submission Timeline Optimization:</strong></h3> <ul> <li><strong>Parallel regulatory processes</strong> maximize efficiency while ensuring jurisdiction-specific requirements are fully addressed</li> <li><strong>Critical path management</strong> identifies dependencies between bench testing, clinical validation, and regulatory submission milestones</li> <li><strong>Regulatory review window alignment</strong> optimizes submission timing for favorable FDA advisory panel review schedules and resource allocation</li> </ul> <h3 id="riskmitigationandcontingencyplanning"><strong>Risk Mitigation and Contingency Planning:</strong></h3> <ul> <li><strong>Regulatory pathway flexibility</strong> with alternative submission strategies based on FDA pre-submission feedback and competitive landscape changes</li> <li><strong>Quality system redundancy</strong> ensures compliance across multiple jurisdictions with harmonized documentation and validation approaches</li> <li><strong>Clinical evidence robustness</strong> provides comprehensive safety and effectiveness data supporting global regulatory approval requirements</li> </ul> <hr> <p>Would you like to expand the plan with additional columns such as Predecessor, Importance, Complexity, External Budget, FTEs Needed, or Functions, Roles, and Skills for complete resource and priority planning?</p> <p>How else can I help refine your robotic surgical platform regulatory submission plan?</p> <div class="clearfix"></div> <p><span class="badge resp-time" style="background: none; border: solid 1px #ccc; color: #333;text-shadow: none; font-weight: normal; font-size: 14px; line-height:1.1;"> <i class="fa fa-clock-o" style=""></i> 1:45 </span></p></div>