Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

  • 150.00 Dollar US$
  • Published date: March 20, 2019
    • Fremont, CA, California, United States

Overview
This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

Why should you Attend
Any firm reprocessing another manufacturer's medical device becomes the legal manufacturer with all the responsibilities for compliance, especially sterility.

Failure to prove sterility is 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 re-sterilized by the user facility, cleaning and sterilization instructions must be precise and validated. 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 webinar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

Areas Covered in the Session
Reasoning behind labeling requirements
Regulatory requirements
Intended use and design
Standards/guidance
Validating cleaning and sterilization

Who Will Benefit
Design Engineers
QA Managers
Quality Engineers
Regulatory Affairs Managers
Manufacturing Engineers
Hospital Operating Room Nurse Supervisors

Speaker Profile
John Chapman, BS, MBA, RAC has over 35 years medical device regulatory & compliance experience and over 15 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking.

Result 0 votes
Joseph Wilcox
0 votes

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