Reprocessing Reusable Medical Devices Cleaning & Labeling Requirements

Aug 19, 2020 - 01:00 PM EDT
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Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices. However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing & validating reusable medical devices.

Course Objective:

Any firm reprocessing another manufacturer's medical device becomes the legal manufacturer with all the responsibilities for compliance, especially sterility. Failure to prove sterility in almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you are reprocessing your own medical device. If intended to be resterilized by the user facility, cleaning & sterilization instructions must be precise and validated.

Course Outline:

  • Reasoning behind labeling requirements
  • Regulatory requirements
  • Intended use & design
  • Standards/guidance
  • Validating cleaning & sterilization

Target Audience:

  • Design Engineers
  • QA Manager
  • Quality Engineers
  • Regulatory Affairs Manager
  • Manufacturing Engineers
Webinar Events
Attend Live Webinar
Aug 19, 2020 - 01:00 PM EDT

Duration: 60 Minutes

Single Attendee

Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version

Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

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