Medical Devices: General testing with 21 CFR Part 11 compliance

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Mecmesin - On-demand event
On-demand
Presenter(s)
Moses Da Rocha
Sharon Smorenburg

Reliable results, trusted compliance: 21 CFR Part 11's role in securing medical device quality testing.

Quality testing of Medical Devices ranges from syringe actuation (break loose and glide), needle sharpness and adhesion strength to Child Resistant Closure (CRC) torque. Even though there are different approaches to these test applications, one thing remains true – the need for compliance to 21 CFR Part 11.

21 CFR Part 11 governs the access to, creation, modification and deletion of data to ensure data integrity.

This webinar with will focus on the importance of Medical Device testing - methods and applications, while showing you how to achieve compliance to 21 CFR Part 11.
 
What You’ll Learn:

  • The importance of Medical Device testing
  • Syringe actuation testing (break loose and glide force)
  • Needle sharpness testing
  • CRC (Child Resistant Closure) testing
  • Factors that affect consistent and repeatable testing
  • Achieving 21 CFR Part 11 compliance