Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

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 resterilized by the user facility, cleaning and sterilization instructions must be precise and validated.

Who Will Benefit:

Design Engineers

QA Managers

Quality Engineers

Regulatory Affairs Managers

Manufacturing Engineers

Instructor Profile:

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. Mr. Chapman has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence for over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification

Note:

Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.

For Registration:

http://www.complianceonline.com/reprocessing-reusable-medical-devices-cleaning-and-labeling-requirements-webinar-training-700831-prdw?channel=sciencedz