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Live Webinar


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 ¡ ¡


¡ ¡ ¡


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

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

Post Market Surveillance for Medical Devices  

The webinar explains the use of post-market surveillance in maintaining your risk management file (ISO 14971) and updating your clinical eva...

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