Post-market Surveillance - Clinical Evaluation and Risk Management


Instructor: Daniel O Leary
Product ID: 705402

  • Duration: 90 Min
This Post-market Surveillance (PMS) webinar will discuss in detail the clinical evaluation and risk management requirements as described in MedDev 2.7/1 Rev. 4, EN ISO 14971:2012 and EN ISO 14971:2012 standards and how they are related. It will also explain some of the recent changes in EU medical device regulations.
Last Recorded Date: Sep-2017


1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)



Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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
Instructor Profile:
Daniel O Leary

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.

Follow us :



Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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).




6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube


Copyright © 2021 MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method