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

Instructor: Frank Stein
Product ID: 706121
Training Level: Intermediate to Advanced
  • 26
  • November 2019
    Tuesday
  • 10:00 AM PST | 01:00 PM EST
    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.

Live Online Training
November 26, Tuesday 10:00 AM PST | 01:00 PM EST | Duration: 90 Min

$249.00
One Dial-in One Attendee
$629.00
Group-Max. 10 Attendees/Location
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Super Deal - Get CD/USB Drive Free!

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$399.00
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CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$429.00

Live + Training CD/USB

$529.00

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Fax: +1-650-362-2367

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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?

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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Managing Your Complaints and Obstacles in Post-Market Requirements

Refund Policy

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.

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