Quality System
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)
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 provide our experience in order to optimize or build up Your quality System in compliance with US and EU regulations.
A Medical Device Quality System is designed to assure that products are Safe and Effective for their Intended Use and Consistently meet the specifications as defined by results of clinical and/or detailed technical design and validation. Different regulation and guideline have to be considered for US or EU market:
US: FDA 21 CFR 820 (Also known as the QSR), Guidance Documents
In QS Regulation, FDA has identified the essential elements that a quality system shall embody for
– design,
– production, and
– distribution
QS Regulation covers:
– Quality Management and Organization
– Device design
– Buildings
– Equipment
– Purchase and handling of components
– Production and process controls
– Packaging and labeling control
– Device evaluation
– Distribution
– Installation
– Complaint handling
– Servicing
– Records
Other Important section from CFR 21: