
 
 
 
 
|
Checking potential hazards during
the product development stage
Some Key Questions:

Which kind of acceleration energy is
to be expected? Which frequency?
Which are the temperature peaks and
variations the product is exposed?
Whats about the delivery conditions
to foreign countrys?
Will the device be operated in
a vehicle?
Are there chemical influences to be
taken into account? Vaporisation,
corrosion, pyrolisation?
Your benefits:
Analysis of the main market application area
Technical specification check-up to avoid sorts of potential
hazards
Evaluation of environmental conditions
(electromagnetic, mechanic dynamic, climatic)
Failure Modes and Effects Analysis (FMEA, FMECA)
Testing interaction of all components within the specific application
range
Assessing the production line by taking endangering factors
into account.
(Analysing the product returns)
Working on risk management and quality management procedures
Documentation
Risk Analysis Directives:
Medical: ISO 14971; IEC 60601-x; EN 62304
Vehicles: QS 9000
Manufacturing, engineering: EN 1050
|
|