Test Methods & Measurement Systems Validation for Medical Device

Early Registration Discount
Early registration until December 9, 2018
Registration from December 10, 2018
1,750 NIS + VAT
Lecturer: Mr. Gadi Shtepel

Date: 19 December 2018
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 1 - Day Course
Hours: 09:00 – 17:00
Price: 1,750 NIS + VAT
Credit Points: 1
SKU: 18659
Course Language: Hebrew
Who should attend
TBA
Test Methods & Measurement Systems Validation for Medical Device
Benefits to the Participants
TBA
Contact us
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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
  • When is TMV Needed?
    • Activities require TMV
    • Compendial and Non-Compendial
  • Documentation
    • Protocols
    • Reports
  • Practical Hands - On Examples
About The Lecturer

Mr. Gadi Shtepel

Gadi Shtepel brings with him over 35 years of experience in the fields of Quality Assurance and Regulatory Affairs- the last 15 years in the Medical Device industry.
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