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 offer support in performing the following tests for electromedical devices:
Special rules for the safety of microwave therapy appliances
- Norm CEI CEI 62-17
Special rules for the safety of transport incubators
- Norm CEI CEI 62-41
- European / International Ref. EN 60601-2-20
Particular requirements for the safety of blankets, bearings and mattresses for the heating of patients for medical use
- CEI CEI 62-97
- European / International Ref. EN 60601-2-35
Special safety standards, including essential performance, of direct blood pressure monitoring equipment
- Norm CEI CEI 62-75
- European / International Ref. EN 60601-2-34
Particular requirements for the safety of short wave therapy devices
- Norm CEI CEI 62-14
- European / International Ref. EN 60601-2-3; EN 60601-2-3 / A1
Special safety rules for electrically operated hospital beds
- Norm CEI CEI 62-95
- European / International Ref. EN 60601-2-38; EN 60601-2-38 / A1
Particular requirements for the safety of electromyographs and devices for evoked potential
- CEI CEI 62-96
- European / International Ref. EN 60601-2-40
Special rules for the safety of neuromuscular stimuli
- Norm CEI CEI 62-24
- European / International Ref. EN 60601-2-10
General requirements for basic safety and essential performance
- Norm CEI CEI 62-5
- European / International Ref. EN 60601-1
Special Safety Standards for High Frequency Electrosurgery Equipment
- Norm CEI CEI 62-11
- European / International Ref. EN 60601-2-2
Special safety standards for cardiac defibrillators
- Norm CEI CEI 62-13
- European / International Ref. EN 60601-2-4
Special rules for the safety of therapeutic and diagnostic laser devices
- Norm CEI CEI 62-42
- European / International Ref. EN 60601-2-22
Special rules for the safety of electrocardiographs
- Norm CEI CEI 62-76
- European / International Ref. EN 60601-2-25; EN 60601-2-25 / A1