Welcome to Microsafe Systems - Medical Device Risk Assessment
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pulled from site's meta descriptionSystem Development and Design at Microsafe Systems
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[[Category:FMECA reliabilityprediction]][[Category:quality procedures]]
Categories:
- AboutUs AutoGen
- FMEA FMEA training risk
- analysis risk
- analysis training
- medical device design
- control design
- control training
- reliability software validation
- process validation
- QSR fda training 510(k)
- PMA CE mark 483 risk
- risk management
- fault tree analysis
- quality system regulation software
- v&v audits
- design reviews
- FDA GMP
- QSR
- Design Control
- software validation
- design controls
- software verification
- verification & validation
- V&V
- medical device
- medical devices
- pharmaceutical
- software development
- GMP audits
- GMP audit
- FDA 483
- warning letter
- FDA inspection
- submission
- submissions
- 510k
- 510(k)
- IDE
- PMA
- CE Mark
- EN 46001
- QSIT
- Quality System Inspection Technique
- risk analysis
- FTA
- FMEA
- risk assessment
- hazard analysis
- fault tree
- failure modes and effects analysis
- FMECA
- 21CFR820
- ISO 13485
- technical files
- MDD
- device directive
- ISO 9001
- training
- in-house training
- automated processes
- computer controlled devices
- assessments
- cgmp
- cGMP