M. L. Reo Consulting LLC

Design & Product Development Consulting • Concept Ideation & Feasibility – Brainstorm product ideas. • Prototyping & Testing – Rapid prototyping and iterative testing to de-risk design decisions. • Design Controls & Risk Management – Document inputs, outputs, testing, and relationship to risk Manufacturing and Operations Consulting • Process Optimization – Implement lean manufacturing strategies to reduce costs and cycle times. • Supply Chain Management – Develop efficient supplier relationships and logistics frameworks. • Scalability & Automation – Plan and execute for higher volume production and automated processes. Regulatory Affairs and Clinical Affairs Consulting • FDA & EU Compliance – Guidance and documentation on regulatory pathways, submissions, and ongoing compliance. • Clinical Study Support – Facilitation of clinical documentation and on-site support. • Documentation & Risk Management – Comprehensive technical documentation and risk assessments. Quality Management Consulting • QMS Implementation – Establish and maintain robust Quality Management Systems. • Audit Preparation & Support – Prepare for audits and inspections, and address non-conformances. Project and Executive Management Consulting • Strategic Planning – Align product roadmaps with business objectives and resource allocation. • Project Management – Ensure projects stay on track with disciplined execution and transparent milestones. • VP or CTO Fractional Support – Provide full-time interim support or fractional support for executive roles in R&D, Ops, Regulatory, Clinical, and Quality Equipment and Fixturing Design and Fabrication • Custom Fixture Design – Deliver specialized and qualified assembly and testing fixtures. • Equipment Prototyping – Deliver functional and qualified equipment for manufacturing processes or test equipment.