About Us
Validation and Quality Control
DQ IQ OQ PQ Validation
Standard Operative Procedures (SOP) (IOP)
Technical file
Risk Analysis
Design & Engineering
Mechanical Design
Rapid Prototiping
Reverse Engineering
FEM Simulation
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
We are a certified company formed by specialized professionals. We offer our support and experience in the field to companies operating in the mechanical and medical device industry.
We provide our service to Medical Device Companies in compliance to ISO 13485 standard.
With the aid of our partners and Subject Matter Experts we can follow the development of a new product, from design input, to validation and verification activities, regulatory and quality path, first series release and production phase.
We can be your certified supplier for your next project.
