Reprocessing Reusable Medical Devices - Cleaning and Labeling 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.

John Chapman
Instructor:
John Chapman
Date:
Thursday, April 4, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 502467

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Live + Recorded
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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. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. John has participated in several FDA remediation projects involving non-compliance with all QMS sub-systems. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.




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