Ventura Solutions provides consulting, staffing, and training services for the Medical Device, Pharmaceutical, and Combination Products industry. Our areas of specialization are listed below: Medical Device & Combination Product Consulting: Design Controls, Risk Management, 21 CFR 820.30, ISO 13485, ISO 14971, Design and Development, Systems Engineering, Project Management, Quality Assurance, Human Factors, IEC 62366, Usability, Design Verification, Design Validation, Statistics, Design History File (DHF) Remediation, Software as a Medical Device (SaMD), Manufacturing, Change Control, Regulatory, FDA Q-Sub, Pre-Sub, Breakthrough Device Program (BDP), Investigational Device Exemption (IDE), 510(k), MDR Medical Device Start-Up & Business Consulting: Co-Development Deals, Licensing Deals, Fundraising, Non-Dilutive Funding, NIH SBIR Funding, Mergers and Acquisitions (M&A), Commercialization, Valuations, Discounted Cash Flow Analysis (DCF), Equity Distributions, Board of Directors, General Management, Leadership, Organizational Development, Building High Performing Teams, Concept Evaluation & Selection, Market Analysis, FDA or EU Regulatory Strategy, Value Proposition Analysis or Creation, Contract Manufacture and Vendor/Supplier Selection and Evaluation Staffing, Direct Placement, & Executive Recruitment Direct Placement, Temp, Temp to Hire, Contract Placements, Executive Recruitment, Medical Device Engineers, Risk Management Engineers, Systems Engineers, Human Factors Engineers, Design Verification & Validation Engineers; Test Method Development Engineers, Materials Engineers, Project Managers; Process Validation Engineers, Process Development Engineers, Quality Engineers, Design Assurance Engineers, Regulatory Affairs Specialists