Reprocessing Reusable Medical Devices Cleaning & Labeling Requirements
Duration : 90 Minutes
John Chapman,
John Chapman, BS, MBA, RAC has over 35 years medical device regulatory 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 performed regulatory due diligence on over a dozen acquisitio Read more
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 Objectives:
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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Design Engineers
• QA Manager
• Quality Engineers
• Regulatory Affairs Manager
• Manufacturing Engineers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
