Presentation was recorded live at Noon (EST) on December 3, 2015.
This is what you’ll learn:
- How to comply with EN ISO 14971:2012
- Why a design fmea (dFMEA) is hard to use
- How to write a risk management plan
- How to document risk activities more efficiently
- New regulations coming from Europe in 2016
Rob has been performing risk management activities since 1990 as a chemical engineer working in the biotech and pharmaceutical industry. He was taught how to use the fmea in 1999 by a fuel systems company where every malfunction leads to an explosion.
FMEAs are a great tool, but only one tool. For medical device design risk analysis we need a better tool. Rob’s design fmea webinar shows you how to use a different tool that will replace your current design fmea and help you get CE Marking approval faster.
Webinar is $129.00– (INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):
This webinar explains how to document your risk management activities during design projects without using a design fmea.
10- Question Exam and Training Certificate available for $49.00:
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
Please note: These products will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
VIEW OUR RISK MANAGEMENT PROCEDURE
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About Your Instructor
Robert Packard is a regulatory consultant with ~25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.