One-Day Virtual Seminar

Lead Auditor EN ISO 13485:2021 and EU MDR 2017/745 - Regulation

BY: Prof. Dr. h.c. 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 medical device regulation EU MDR 745/2017 in the European Union has a lot of requirements. This regulation is also stronger connected to the EN ISO 13485:2021. The first key for the understanding and the implementation of the changes is the knowledge about the relationship between the EN ISO 13485:2021 and the EU MDR 2017/745. The second key is to understand, which parts of the EU MDR 2017/745 are not covered by the EN ISO 13485:2021. These not covered paragraphs and requirements must be additional implemented into the quality management system.

Learning Objectives:
  • Introduction, who must apply the EU MDR 2017/745 requirements?
  • Overview about the changes of the EU MDR 2017/745 regarding quality management
  • What are the relationships between the EN ISO 13485:2021 and the EU MDR 2017?
  • Which requirements of the EU MDR 2017/745 are not covered by the EN ISO 13485:2021?
  • Smart and fast ways to implement the changes in your quality management system
  • Fast track internal audit to approve the changes
Areas Covered:
  • The scope of the EU MDR 2017/745
  • The obligations and roles of the EU MDR 2017/745
  • How work the regulation and the EN ISO 13485:2021 together?
  • Processes required by the EU MDR 2017/745
Who will Benefit:

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

  • medical device manufacturer,
  • importer,
  • distributors
  • dealers
Day 01(9:00 AM - 4:00 PM PST)
  • 09:00 – 09:45: What are the topics in the EU MDR 745/2017 (Summary)
    A brief summary of the topics to get an overview about the MDR. The focus is performance and safety. Both need to be approved by verification and validation actions in pre-clinical activities (physically, chemically and biologically lab tests) and in clinical study activities or clinical evaluations. The risk classes and the regulatory pathway for high risk products changed.
  • 09:45– 12:30: The new route of the conformity assessment under EU MDR 745/2017 and the expectations of auditors
    What is new in the conformity assessment and what are the consequences for the time line, for the budgets and the organization of the activities to create a technical file according the MDR. Risk class III and IIb will have additional assessments by the EU-commission. This expand the time to market.
  • 12:30 – 13:30: Lunch
  • 13:30 – 14:30: The relationships between EN ISO 13485:2021 clause 0 – 6 and EU MDR 745/2021
    The EN ISO 13485 references 37 times the MDR. How to understand the references and what are the required activities according the standard and the MDR. What are the expectations of an auditor?
  • 14:30 – 16:00: The relationships between EN ISO 13485:2021 clause 7 - 8 and EU MDR 745/2021
    The EN ISO 13485 references 37 times the MDR. How to understand the references and what are the required activities according the standard and the MDR.
  • ing long-term animal testing.
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.

Register Now

Online using Credit card

For discounts on multiple registrations, contact customer care at +1-888-771-6965.

Other Registration Options

By order form / PO#

Payment Modes

By Check -

To pay by check please contact

By Wire -

Register / Pay by Wire TransferPlease contact us at +1-888-771-6965 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event »

Terms & Conditions to register for the Seminar/Conference/Event

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 @

Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
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.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future FDATrainingAlert event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

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.

In the event FDATrainingAlert cancels the seminar, FDATrainingAlert is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending FDATrainingAlert conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by FDATrainingAlert for marketing, archiving or any other conference related activities. You agree to release FDATrainingAlert for any kind of claims arising out of copyright or privacy violations.

You Recently Viewed