JAMES FREITAS Engineering Consulting, LLC

Independent contractor providing engineering, development, manufacturing, and operational support. JAMES FREITAS Engineering Consulting, LLC PRINCIPAL ENGINEERING PROFESSIONAL ■ Biotech & Medical Device Proficiency ■ Regulatory Compliance and Audit Inspection Readiness ■ Startup Experience ■ Product Development, Process Development, Supplier Development, Manufacturing NPI Transfer ■ Design Transfer, V&V Testing, Risk Assessments, DFM, DFA, DFT ■ Industrial & Manufacturing Engineering Expertise ■ Validation Services (PV, MVP, TMV, CV, Software, Packaging/Transit, Sterilization, etc.) ■ Clean Room (CER) Construction, Layout, Setup, Validation and Commissioning ■ Implant Expertise - Class III & Class II Implant/Component Development & Testing Management ■ Operational & Manufacturing Setup and Support ■ Standard Cost Determination, BOM Cost/Financial Models, Cost Reduction ■ Stabilizing, Streamlining & Ramping Manufacturing ■ Quality Engineering Services Strategic partner within the Preferred Regulatory Consulting network: https://preferredregulatoryconsulting.com/Development.html