Noblitt & Rueland Home Page, FDA & International Medical Device Consulting & Training Services
Description
pulled from site's meta descriptionFDA GMP, QSR, Design Control, software development, software validation, V&V, risk, hazard, submissions, 510(k), IDE, PMA, consulting and training.
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Categories:
- AboutUs AutoGen
- 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