Live Webinar
on
Post Market Surveillance for Medical Devices
Date & Time: Thursday, March 22, 2012
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: Dan OLeary
Location: Online
Price : $245.00
Register Now
(for one participant)
Instructor Profile:
Overview: Post market surveillance is changing, not only in the US, but also in
Dan OLeary President, Ombu Enterprises
the EU and Canada. New rules and regulations are emerging in the countries where the devices manufacturers market their products. The sheer volume of rules and regulations can be daunting, but the differences in each geographic market can be scary. This webinar explains the aspects of post market surveillance that will help you understand and implement them. The webinar explains the use of post-market surveillance in maintaining your risk management file (ISO 14971) and updating your clinical evaluation (MDD Annex X). In addition, the webinar compares and contrast the rules for adverse event reporting in the US, EU, and Canada.
Why you should attend:
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management. ...more
Post market surveillance can be complicated, but by breaking it down into its parts, it can be accessible. With the understanding of the parts, you can develop and implement a comprehensive system that Suggest a Topic More Webinars will help you stay in compliance. By attending this webinar, you will find out what you need to do and be well on the way to effective Your Necessity is our Priority performance.
Areas Covered in the Session: l l
The Structure of Post Market Surveillance US System ¡ Complaints (QSR)
Medical Device Reports Corrections and Removals International Systems ¡ ¡
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Complaints (ISO 13485) EU Vigilance EU FSCA and FSN
¡ Canada Adverse Event Reporting Post Production Information Collection ¡ ¡
Risk Management (ISO 14971) Clinical Evaluation (MDD Annex X)
Click here to register for this webinar Who Will Benefit: l l l l
Quality Managers Regulatory Affairs Managers Risk Managers Design Control Managers
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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