Regulatory Services
FDA 21 CFR 820/QMSR and ISO 13485 compliant Medical Device Regulatory Services
Whether establishing a Quality Management System for the first time, managing an FDA inspection, or transitioning to QMSR (effective February 2, 2026), Springboard Solutions provides the following regulatory services to medical device companies and life sciences organizations.
People
• Regulatory Staffing Gap Analysis (internal & external resources)
• Job Description Development (per FDA / ISO requirements)
• Regulatory Training Program Development & Delivery (all staff including C-Suite)
Process
• QMS / QMSR (FDA 21 CFR 820) & ISO 13485 Gap Analysis & Implementation
• SOP Development & Optimization (design HW/SW/FW, supplier, manufacturing, service)
• Requirements Management & Design History File (DHF) Construction
• Risk Analysis Implementation (ISO 14971: Hazard Analysis, DFMEA / PFMEA / UFMEA)
• FDA 510(k) Submission Support
• FDA Inspection Preparation, Response & 483 Observation Remediation
• CAPA Program Development & Management
• Complaint Handling Process Implementation (top FDA warning letter citation)
• Post-Market Surveillance Process Implementation
• QMSR Transition Planning & Implementation (February 2026 regulatory change)
Tools
• Design Tools Gap Analysis & Integration
• Quality Inspection & Service Tools Gap Analysis
• QMS Software Selection & Implementation (e.g., MasterControl)
• Requirements Management Tool Implementation (e.g., JAMA)
• Business Systems Integration (CAD → PLM → QMS → MES → ERP)
Technology
• Medical Device Technology Analysis
• Technical Core Competency Analysis & Transition Planning
• Medical Device Standards Compliance (IEC 60601, IEC 62304, IEC 61508, ISO 14971)
• AI-Enabled QMS / QMSR Process Optimization (in partnership with Valere)
Business
• Domestic Regulatory Strategy (FDA QMSR, 510(k), Class I / II / III)
• International Regulatory Pathways (TGA Australia, CE Marking / EU MDR)
• FDA Warning Letter Response & Remediation Strategy