Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017


Instructor: Frank Stein
Product ID: 706121
Training Level: Intermediate to Advanced

  • Duration: 90 Min
This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create the reports. The understanding of the changes and how to implement last-minute changes until May 2020 is essential to keep your certificates and to sell your products after May 2020 to the European Union.
Last Recorded Date: Jun-2020


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Read Frequently Asked Questions

Why Should You Attend:

You should attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. Your implementation time until May 2020 is short and need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the “Post Market Surveillance Activities” and the frequently reporting to the Notified Bodies and the Authorities. Attend this webinar to keep yourself up to date. Learn how to understand the requirements and how to create the reports.

Learning Objectives:

  • Introduction, who must apply the new EU MDR 745/2017 requirements
  • Overview about the changes of the EU MDR 745/2017 regarding the “Post Market Surveillance” - activities
  • Explaining of each change
  • Smart and fast ways to implement the changes in your quality management system
  • Fast track internal audit to approve the changes
  • Who is responsible for the activities?
  • Which (new) roles in the company required?

Areas Covered in the Webinar:

  • Responsibilities for “Post Market Surveillance” - activities
  • What reports are required?
  • What is the input for the reports?
  • How to create the reports?
  • How often the reports required?
  • Adjustments in the management review
  • How to work with the output of the reports in the quality management system processes and the technical documentation?

Frequently Asked Questions:

  1. We are manufacturer of implantable diaphragm pacemaker and we only sell low volume. Can we use number of patients when doing PMS rather than number of devices sold?
  2. For example we sold 30 for the year. we received a 2 complaints. Do we calculate the 2 complaints based on the devices sold or can we use number of active patients? complaint linked to use of the device?
  3. For Post-market clinical follow-up if I understood correctly it is NB that will send to EUDAMED but not clear for ICSR reports for 15 day reports. For vigilance reporting for 15 day - will manufacturer be required to report directly to EUDAMED?
  4. What about if the complaint was due to user error? Do you need to include this to the PMS as a complaint?
  5. Package damage can be from delivery person/agency also, so are we responsible to note?
  6. Do you need to do PMCF if you a have good PMS report?

Who Will Benefit:

CEO’s, medical advisors, medical department manager, quality/regulatory affairs manager, quality representatives of

  • medical device manufacturers
  • importer
  • distributors
  • dealers
Instructor Profile:
Frank Stein

Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.

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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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