Ventura Solutions

Medical Equipment ManufacturingIllinois, United States11-50 Employees

Ventura Solutions provides End-to-End consulting, staffing, and training services for the Medical Device and Combination Products industry.
 
We provide consulting, staffing, and training solutions in the following areas:
 
-Design Controls
-Risk Management
-Verification & Validation
-Design and Development
-Project Management
-Quality
-Regulatory
-Human Factors
-DHF & Quality System Remediation
-Software as a Medical Device (SaMD)
-Statistics
-Clinical Affairs
-Market Access
-Funding
-NIH SBIR Grants
-Start-Ups
 
Ventura Solutions is your one-stop shop for getting your product to the market or keeping it compliant.

Detailed list of areas of expertise:

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, Equity Distributions, Board of Directors, Leadership, Organizational Development, Building High Performing Teams, Concept Evaluation & Selection, FDA or EU Regulatory Strategy, Value Proposition

Staffing, Direct Placement, & 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

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