Design & Engineering

Mechanical Design
Rapid Prototyping
Reverse Engineering
FEM Simulation

Quality and Validation

Quality System Support
VMP - DQ IQ OQ PQ Validation
Standard Operative Procedures (SOP) (IOP)

Regulatory

Technical File / Design Dossier
Design Control
DHF Design History File
Risk Management Process
Clinical Evaluation

Testing

Mechanical Testing
Analysis on Plastics
Biological Safety Evaluation

Injection Molding

Injection Molding

We work for our client in order to get their product on the market efficiently and effectivly.

We provide a full range of regulatory service, with particular focus to:

• Technical File / Design Dossier
• Design Control
• DHF Design History File
• Risk Management Process
• Clinical Evaluation

Our regulatory expertise includes regulatory consultants and scientists who have extensive experience dealing with Autorities of U.S. and EU.