Reprocessing Reusable Medical Devices Cleaning & Labeling Requirements

John Chapman
Jul 16, 2019 - 01:00 PM EST
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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
Jul 16, 2019 - 01:00 PM EST

Duration: 60 Minutes

Single Registration

Group 3 to 5

Group 6 to 10

Training CD-DVD

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

Recorded video

Recorded video session

Speaker: John Chapman,

John Chapman, BS, MBA, RAC has over 35 years medical device regulatory experience and over 15 years experience with the European Unions medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has 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. RAB Accredited Lead Auditor Course Certificate1996. 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. John has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations. He has also presented live on-line seminars on various regulatory and quality system subjects.

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