Post-market Surveillance - Clinical Evaluation and Risk Management

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.

• MedDev 2.7/1 Rev. 4 describes the initial Clinical Evaluation, but also provides considerations on the update content and frequency.
• EN ISO 14971:2012 requires collection and analysis of post-production information to verify continued risk acceptability.
• EN ISO 14971:2012describe the Post-market Clinical Follow-up process used to gain information about specific situations such as residual risk.

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:

• Identify the source of the requirements in the MDD
• Explain the connection between these activities before and after the initial CE Mark
• Develop a framework for Post-market Surveillance (PMS)
• Show how PMS feeds the three crucial elements
• Describe how these elements supplement each other
• Identify some of the changes from the EU-MDR

Bonus Material

Participants receive a checklist to help ensure correct implementation of the processes and procedures.

Who Will Benefit:

• Risk Managers
• Clinical Affairs Professionals
• Product Surveillance Professionals
• Regulatory Affairs Professionals
• Data Analysts

Daniel O Leary
President, Ombu Enterprises, LLC

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.

Topic Background:

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.

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