Wag Hanna

About Wag Hanna

I\'m a systems and compliance expert helping MedTech companies bring safe, effective, and…

Experience

1. President

   Medical Systems Consult, Llc

   Jan 2016 — Present

   Medical Systems Consult, LLC is a product development consulting company specializing in regulated medical device development, technical product management, systems engineering, risk management, project management and regulatory compliance for class II and class medical devices, software as a medical device, and IVD biopharmaceutical technologies. Experienced in all aspects of regulated product development life cycles. We can add to your team temporary contractors or take on project-level responsibility offering you an integrated team, complete project management, verification & validation, and design transfer to manufacturing. Specialties:> Technical Product/Project Management > Requirements Management > Safety/Security/Usability Risk Management > Mobile/web apps, cloud, IoT, AI/ML, Embedded, DSP, real-time, full stack software > FDA QSR 21 CFR 820.30 Design Controls > ISO 13485 Quality Management System > FDA 510k, PMA, IDE, EU CE Mark > ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 60601 Learn more at

Education

• Carleton University

  Bachelor of Engineering, Systems

Skills

• Cross-Functional Team Leadership
• Risk Management
• Product Management
• Product Safety
• Systems Engineering
• System Architecture
• Iec 62304
• Industrial Safety
• Management
• Design Control
• Embedded Systems
• Iec 60601
• Integration
• Wireless
• Engineering Management
• Program Management
• Iso 14971
• Business Development
• Medical Device Directive
• Embedded Software
• Patient Safety
• Strategic Partnerships
• Flight Safety