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Regulatory submissions
Assisted with submissions to the following agencies: FDA, UL, CSA, TUV, VDE, ISO
Compliance
For many projects, GMP plans were written for device production, products were designed to meet international
regulatory requirements (e.g. UL, CSA, TUV, VDE),
and/or ISO 9000 procedures were generated (leading to successful certification).
Reliability and Safety
Analysis plus Life Testing
To help understand the reliability and safety of numerous systems, several quality analysis techniques were
employed. These techniques included Fault Tree Analysis (FTA), Failure Modes and Effects Analysis (FMEA),
Highly Accelerated Life Testing (HALT), and Life Test programs. Based on these techniques the following
could be estimated: Mean Time Between Failure (MTBF), reliability, safety, and availability of critical systems.
As part of the analysis processes, redesigns were suggested. Where redesigns were not practical,
alternative actions were recommended such as scheduled maintenance, redundancy, and/or close monitoring
(sometimes automated by alarm circuitry).
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