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Test Methods & Measurement Systems Validation for Medical Device
Have a question? We got all the answers
Issues to be covered
- Regulatory Requirements
- FDA
- Europe
- Applicable Standards
- Measurement System Definitions
- MSA-TMV
- Resolution
- Sensitivity
- Accuracy
- Linearity
- Stability
- Variability
- Repeatability
- Reproducibility
- Basic Statistics – Refresher
- Measurement System Analysis
- Gage R&R Methods
- Type 1
- Type 2
- Type 3
- Type 4
- Gage R&R Methods
- When is TMV Needed?
- Activities require TMV
- Compendial and Non-Compendial
- Documentation
- Protocols
- Reports
- Practical Hands – On Examples
About The Lecturer
