ComplianceOnline

This course will give an introduction into the new in vitro diagnostic medical devices regulation EU IVDR 2017/746 in the European Union. This new regulation has a lot of new requirements and is also stronger connected to the EN ISO 13485:2016. The understanding of these changes and how to implement changes until May 2022 is essential to receive the new certificates until May 2022. The first key for the understanding and the implementation of the changes is the knowledge about the new requirements for the IVD-products. The second key is to understand, which changes need the quality management system according the ISO 13485:2016, which need more processes under the new IVDR as outlined in the ISO 13485:2016. These not covered paragraphs and requirements must be additional implemented into the quality management system until May 2022. The time is short and immediately actions are required. Without the new certificates your sales activities in Europe are interrupted.

Learning Objectives:

  • What are the requirements of the new EU IVDR 2017/746?
  • Which Companies must apply the new EU IVDR 2017/746?
  • How to implement the new EU IVDR 2017/746 in a smart way into a medical device quality management system and how to apply the new regulation on your products to receive a new product certificate until May 2022?
  • How work the EU IVDR 2017/746 product reviews?
  • How work the EU IVDR 2017/745 quality management audits?
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will benefit:

  • CEO’s of companies, which sell in vitro diagnostic medical devices to Europe
  • Regulatory Affairs Managers of companies, which sell in vitro diagnostic medical devices to Europe
  • Quality Managers of companies, which sell in vitro diagnostic medical devices to Europe
  • Quality Representatives of companies, which sell in vitro diagnostic medical devices to Europe
  • Other managers, which need to deal with regulatory or quality guidelines
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Day 01(8:30 AM - 4:30 PM)
  • 8:30 AM - 8:59 AM: Registration. Meet & Greet.
  • 9:00 AM -11:00 AM: Introduction into EU IVDR 2017/746 (Overview about this regulation, structure, scope)
  • 11:00 AM - 12:00 Noon: The new approach of the risk classes to classify the IVD - products
  • 12:00 Noon -1:00 PM: Lunch
  • 1:00 PM - 2:30 PM: The new approach of the conformity assessment procedure (workflow, technical documentation, clinical data, post market surveillance, post market clinical follow up)
  • 2:30 PM - 3:00 PM: Refreshments Break.
  • 3:00 PM - 4:30 PM: The new approach of the conformity assessment procedure (workflow, technical documentation, clinical data, post market surveillance, post market clinical follow up)
Day 02(8:30 AM - 4:30 PM)
  • 8:30 AM - 8:59 AM: Registration. Meet & Greet.
  • 9:00 AM -11:00 AM: How to deal with clinical data and to approve product performance and safety
  • 11:00 AM - 12:00 AM: Frequently Post – Market – Surveillance and Post Market Clinical Follow up reporting to Notified Bodies and Competent Authorities
  • 12:00 Noon -1:00 PM: Lunch
  • 1:00 PM - 2:30 PM: Reporting to authorities (incidents, field safety, corrective actions, changes)
  • 2:30 PM - 3:00 PM: What are the expectations of European Notified Bodies and Competent Authorities?
  • 3:00 PM - 4:30 PM: Answers & Questions
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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.

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Register Now

Online using Credit card

$1,699.00

Seminar One Registration

December 16-17, 2019, San Francisco, CA
(For Registrations till November 2, 2019 - $1699)
(For Registrations after November 2, 2019 - $1899)




Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

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Palo Alto, CA 94303
USA

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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:
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.

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 5 working days before the seminar date. Please bring the pass to the venue of the event.

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By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location:

    San Francisco, CA
    (Venue to be announced shortly)

    December 16-17, 2019

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    We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
    • Exhibit Space
    • Free event pass
    • Speaking opportunity
    • Social media campaign

    For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

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