GlobalCompliancePanelto organize RAPS pre-approved webinar on "Reprocessing REUSABLE Medical Devices -Cleaning & Labeling Requirements"
"Reprocessing REUSABLE Medical Devices -Cleaning & Labeling Requirements" is the topic of aRAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on October 23.
- Wilmington, NC (1888PressRelease) October 23, 2012 - There is a difference between single use devices and reusable devices. As the term suggests, single use devices (SUDs) are meant for a single intended use in the patient, after which they have to be discarded. There are clear regulatory guidelines on this kind of product.
However, there is heated debate as far as reprocessing reusable medical devices are concerned, because of the inherent risk of contamination and potential for infection. A medical device is said to be a reusable one even when a firm reprocesses a medical device manufactured by another firm. When stringent regulatory guidelines on reusable devices are not adhered to fully, they attract recall and all other kinds of responses.
This applies even when a firm is reprocessing a device it itself manufactured. In order to avoid this, rules relating to sterility and cleaning have to be adhered to. Instructions for re-sterilizing and cleaning have to be clear and unambiguous.
This webinar will give an idea of all the regulatory requirements needed for sterilizing and cleaning reusable medical devices. Participants will get to know what processes to follow in order to avoid actions from regulatory authorities.
Areas Covered in the Session:
o Reasoning behind labeling requirements
o Regulatory requirements
o Intended use & design
o Validating cleaning & sterilization
When:October 23, 10:00 AM PDT | 01:00 PM EDT
John Chapman, BS, MBA, RAC has been in the medical device regulatory industry for over 30 years, over 10 of which have been spent with the European Union's medical device directive, 93/42/EEC. Leading two device companies to ISO quality system certification and CE marking is one of the highpoints of his highly successful career.
In the course of performing regulatory due diligence on over a dozen acquisitions in the past 12 years, John has been exposed to numerous Quality Systems, including consent decrees. This work has also acquainted him with many notified bodies.
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.
The webinar will benefit
o Design Engineers
o QA Manager
o Quality Engineers
o Regulatory Affairs Manager
o Manufacturing Engineers
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com