Springboard Solutions provides the following tactical services to medical device companies and life sciences organizations.

People

• Cross-Functional Team Building & Leadership

• Program & Project Management

• Fractional VP Engineering / VP Quality & Regulatory

• Operations Team Leadership

Process

• Design Control Process Implementation

• Manufacturing Process Implementation

• FDA 510(k) Submission Support

• FDA Inspection Preparation, Response & 483 Remediation

• CAPA Program Implementation

• Requirements Management Process Implementation (JAMA)

• Risk Analysis Implementation (ISO 14971: DFMEA / PFMEA / UFMEA)

Tools

• Design Tools Integration

• Business Systems Integration (SolidWorks → MasterControl/PLM → Oracle Agile/ERP → JAMA)

• QMS Software Selection & Implementation (e.g., MasterControl)

• Requirements Management Tool Implementation (e.g., JAMA)

Technology

• Systems & Electrical Engineering Leadership

• Technology Supplier Qualification & Risk Assessment

• AI Tool Integration & Compliance Workflow Automation (with Valere)

Business

• Export Control Analysis & Implementation (EAR / ITAR)

• International Regulatory Standards Implementation (TGA Australia, CE Marking / EU MDR)

• Industry-Specific Regulations & Standards Planning