At AJ Medical, we offer the following services
REGULATORY
- Design Control
- 510(k) requirements evaluation
- 510(k) submission gap analysis
- Review predicate devices
- Prepare 510(k) application
- Submit and correspond with FDA on client’s behalf
- Perform as intermediary between the FDA and Client
ENGINEERING
- Mechanical
- Electronics
- Injection molding
- Software
- Automation
- Design for Manufacturing
- In-house Machine Shop
SOME OF OUR MANY FIELDS OF EXPERIENCE INCLUDE
- Ophthalmology
- Cardiology
- Respiratory
- Neurology
- Genetics
CONTRACT MANUFACTURING
- Clean Room Environment
- Manual and Automated Assembly
- Process Design and Development
- Pilot and Production Tool Design
- Production Assembly Capabilities:
- Electromechanical Assembly
- Ultrasonic and Laser Welding
- Chemical Bonding
- High Volume Consumable Product Assembly
- High Volume Custom Pack and Kitting Assembly
- Product and Process Verification Planning
- Verification Testing
ANALYTICS
- Digital prototyping
- Additive manufacturing
- Drop and impact test
- Product performance
- Shape Optimization
- Finite Element Analysis
- Mechanical
- Thermal
- Computational Fluid Dynamics
- Electromagnetic
