Why Should You Attend:
Post-market Surveillance (PMS) is a crucial element of putting a device on the market in the EU. The PMS process feeds information to other processes to ensure they are current. Two of the most important are the Clinical Evaluation update and the Risk Management update. This presentation explains the updates and shows how they are connected. In addition, the Post-market Clinical Follow-up provides additional information in specific cases.
These three tightly linked processes provide the basis to show the device continues to be safe and effective. With the publication of the EU-MDR, these concepts remain the same, but some of the details will change. The presentation explains some of these changes.
Areas Covered in the Webinar:
Participants receive a checklist to help ensure correct implementation of the processes and procedures.
Who Will Benefit:
Dan O'Leary is 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 Master’s Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.
Putting the initial CE Mark on a medical device under the MDD requires a process to meet the Essential Requirements in Annex I. The Clinical Evaluation process from Annex X and the Risk Management process from EN ISO 14971:2012 support the CE Mark process.
After placing the device on the market, i.e., after CE Mark, the manufacturer establishes and maintains “systematic procedure to review experience gained from devices in the post-production phase” This is usually called Post-market Surveillance or PMS.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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