Project & Program Management

Project & Program Management

We provide experienced project and program management leadership to help medical device companies deliver complex initiatives on time, within budget, and in full compliance with regulatory requirements. From single product launches to enterprise-wide quality system transformations, we bring structure, accountability, and deep industry expertise to every engagement.

What We Offer

• New Product Development (NPD) Program Management — We lead cross-functional teams through the full product development lifecycle, managing design controls, stage-gate milestones, resource planning, and regulatory timelines from concept through commercialization.
• Regulatory Submission Project Management — We coordinate and manage the preparation of FDA submissions (510(k), PMA, De Novo) and CE marking technical files, keeping teams aligned and submissions on schedule.
• Quality System Implementation & Remediation — We manage the planning, execution, and closure of QMS implementation, gap remediation, and corrective action projects — ensuring deliverables are completed, documented, and audit-ready.
• Cross-Functional Team Leadership — We facilitate alignment across engineering, quality, regulatory, operations, and clinical teams, driving clear ownership, decision-making, and communication throughout the project.
• Schedule & Risk Management — We develop and maintain project schedules, identify risks early, and implement mitigation strategies to protect timelines and minimize downstream impacts on product launch or regulatory approval.
• Program Governance & Reporting — We establish governance frameworks, KPIs, and executive reporting cadences that give leadership real-time visibility into program health, milestones, and critical issues.
• Vendor & Contract Management — We manage relationships with CROs, CMOs, consultants, and other third-party partners to ensure deliverables are met and quality standards are maintained throughout the supply and development chain.

Why It Matters

Medical device development is uniquely challenging — regulatory complexity, design control requirements, and cross-functional dependencies create significant project risk. Without experienced program management, timelines slip, costs escalate, and compliance gaps emerge. Our leadership keeps your projects moving forward with the rigor and discipline the industry demands.

Who We Serve

We partner with medical device startups, growing manufacturers, and established companies that need experienced program leadership — whether as a fractional resource, interim support, or dedicated project management for a critical initiative.