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

TS Quality & Engineering is a 

ISO 13485:2012

Certified Company

We provide our service to Medical Device Companies in compliance to ISO 13485:2012 standard.

This allow us to daily foster and improve the quality of services and support to our clients.

We are certified for the following services:

“Design and Provision of consulting services for design, transfer to production, process validation and support to quality assurance and regulatory affairs functions as regards implantable medical devices intended for orthopaedics, trauma and neurosurgery and related instruments.”