One Day Virtual Seminar

How to Create Clinical Evaluation According to EU MDR 2017/745 Article 61 and Annex XIV?

BY: Frank Stein, Senior Medical Device Expert, Nemius Consulting GmbH

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

Coming soon.. Please contact customer care for new schedule
  • Course Description
  • Agenda
  • Speaker
  • Price/Register

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 clinical data, “Clinical Evaluation-Process” and the new requirements and how this process is connected to other processes in the quality management system according ISO 13485:2016 and EU MDR 2017/745. The understanding of this changes and how to implement changes until May 2021 is essential to keep your certificates and to keep the market entry open.

Why You should 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 and your technical documentation. Your implementation timeline until May 2021 is short and need smart ideas to reach the right level to pass the quality management audit and technical documentation audit and review by your notified body.

Who will Benefit:

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

  • medical device manufacturer
  • importer
  • distributors and
  • dealers

who work with European Union

Day 01(10:00 AM - 6:00 PM EST)
  • Learning Objectives:
    • Introduction, who must apply the new EU MDR 745/2017 requirements
    • Overview about the changes of the EU MDR 745/2017 regarding “clinical evaluation” of your products
    • Explaining of each change
    • Smart and fast ways to implement the changes in your technical documentation
    • Fast track internal audit to approve the changes
  • Areas Covered in the Seminar:
    • How to define a “Clinical Evaluation-Process”?
    • How to create the new clinical evaluation for the Notified Body and the Competent Authorities?
    • How to gather the data input for the clinical evaluation?
    • How is the Clinical Evaluation-Process” connected to post market surveillance, customer feedback, complaints and vigilance?
Frank Stein
Frank Stein Senior Medical Device Expert, Nemius Consulting GmbH

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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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

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We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

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