Test Methods & Measurement Systems Validation for Medical Device

Conducted by: Mr. Gadi Shtepel
SKU: 20659
Print version

Share a colleague:

Date:  5 February, 2020
Course location: Kfar Maccabiah, Ramat Gan
Duration: 1-Day Course
Hours: 09:00 - 17:00
Credits: 1
Course Language: עברית

Course price: ₪1,850 + VAT
Early registration is Closed
Do you have a subscription? You deserve more

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
  • When is TMV Needed?
    • Activities require TMV
    • Compendial and Non-Compendial
  • Documentation
    • Protocols
    • Reports
  • Practical Hands – On Examples

About The Lecturer

Gadi Shtepel
Gadi Shtepel brings with him over 35 years of experience in
Read more

Leave a Reply

    [anr_nocaptcha g-recaptcha-response]