Member Since 1982
Gene Zamba Consulting Services
Product Development
We provide complete engineering and regulatory compliance solutions to companies, surgeons, or anyone wanting to get a medical device to market.
3D printing of components
• Product development from concept to end user
• Machine shop, injection molding, and cleanroom assemblies
• Concept Brainstorming & Product Development
• SolidWorks 2019 Modeling and Drafting
• FEA
• Prototyping
• Component Sourcing
• Specifications (Components & Assemblies)
• Verification Testing & Reports
• Packaging Design & Validation
• IP Research
• Documentation
• Quality System (Auditing, SOP Revision, Systems Implementation, Training)
• Design Validation
• Design Reviews
• Risk Analysis
• Design FMEA
Quality and Regulatory Affairs:
-Over 180 successful 510k Submissions & PMA’s
- International submissions and compliance, CE, EU, Health Canada, Australia, China
- CAPA
-Create and Review Product Change "Letters to File"
-FDA Facility Registration and Device Listing
-FDA Good Manufacturing Practices (GMP), Quality System
-FDA Quality System Audit Inspection Support
-Medical Device Directive Compliance and Support
-Medical Device Reporting and Complaint System Compliance
-Quality and Regulatory Affairs Management
-ISO 13485-2016 Certification
Project Business Development
We will build your project business plan and action plans
Product Development
Complete Engineering Services
CAD Models and Drawings on SolidWorks
3D Printed Prototyping
Injection Molding, CNC Machining
Packaging and Sterilization
Regulatory Affairs
FDA ,CE and International Submissions
Electrosurgical and disposable Products
Benjamin R.
Online Co.
Orthopedic Implants, Catheters, Monitors, Diagnostic Systems
Brick & Mortar Retail Co.
FDA, CE , International Regulatory Submissions and Compliance
Truly Services LLC