Page Business Solutions provides the strategic oversight and operational framework necessary for Medical Device companies to scale from concept to commercial success. We leverage decades of leadership at firms like Sensydia, Neuronetics and Bioness to solve high-stakes challenges in manufacturing, digital infrastructure, and corporate governance.
Bridging the gap from R&D to full-scale production through strategic vendor selection, global supply chain resilience, and transfer optimization.
- Global Contract Manufacturing Selection & Negotation
- Prototyping to Mass Production Scaling
- Component-to-Finished-Goods Strategy (Sub-suppliers & Assemblies)
- Cost of Goods (COGS) Analysis & Reductions
- Difficult Component Procurement & Lead-time Mitigation
Leveraging modern tech stacks to streamline operations. We specialize in organizational needs assessments and the integration of enterprise software to drive data security and internal efficiency.
- ERP & CRM Needs Assessment & Implementation (Salesforce.com, NetSuite, Dyanmics, etc.)
- Business Intelligence (BI) Platform Integration & Data Intelligence
- Cybersecurity Framework & Audit Risk Mitigation
- Process Automation (Transitioning from manual/paper to electronic systems)
- M&A IT Infrastructure Integration
Building lean, audit-ready QMS frameworks that support rapid innovation without sacrificing regulatory compliance.
- Quality System Review (ISO 13485, MDSAP, MDR, FDA CFR, etc.)
- M&A Technical & Quality Due Diligence
- EU MDD to MDR Transition
- 510(k) Submission Strategy & Planning
- CAPA Guidance & Process Validation
Providing strategic oversight for medical device boards and executive teams, focusing on operational risk, corporate governance, and long-term scaling.
- Fractional COO & President-level Advisory
- Board Membership (Audit Committee & Strategy)
- M&A Buy-side & Sell-side Operational Due Diligence and Integration
- Departmental Integration & Operational Turnarounds
- Cost Containment & Process Optimization