ComplianceOnline

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

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

September 18, 2020 (10:00 AM - 6:00 PM EDT)


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?
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Frank Stein

Prof. Dr. h.c. 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 by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

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$1,699.00

(One Dial-in One Attendee)

September 18, 2020, Virtual Seminar

$8,665.00

Group-Max. 10 Attendees

September 18, 2020, Virtual Seminar



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Note: In view of Coronavirus situation and travel advisory issued, ComplianceOnline will waive off all cancellation charges for the registrations till September 30, 2020.

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 @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:

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

Cancellations and substitutions for In-person Seminars:

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 before 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 ComplianceOnline 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 ComplianceOnline cancels the seminar, ComplianceOnline 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.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% 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 training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
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