EU IVDR 2017/746 - the new EU regulation for invitro diagnostic
Instructor:
Frank Stein
Product ID: 706170
Training Level: Intermediate to Advanced
- Duration: 90 Min
Why Should You Attend:
The new in vitro diagnostic medical devices regulation EU IVDR 2017/746 in the European Union has a lot of new requirements. This new upcoming regulation 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 action is required. Without the new certificates your sales activities in Europe are interrupted.
Learning Objectives:
- Introduction, who must apply the new EU MDR 2017/746 requirements?
- Overview about the changes of the EU MDR 2017/746 regarding quality management
- What are the interfaces between the EN ISO 13485:2016 and the EU IVDR 2017/746
- Which new requirements of the EU IVDR 2017/746 are not covered by the EN ISO 13485:2016?
- Smart and fast ways to implement the changes in your quality management system
- Fast track internal audit to approve the changes
Areas Covered in the Webinar:
- The new scope of the EU IVDR 2017/746
- The obligations and roles of the EU IVDR 2017/746
- How work the regulation and the EN ISO 13485:2016 together?
- New and updated processes required by the EU IVDR 2017/746
- How to implement the required changes until May 2022?
Who Will Benefit:
CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of
- IVD manufacturers
- IVD importers
- IVD distributors and
- IVD dealers
who work with European Union
Instructor Profile:
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.
More Training By Experts
- Supplier Evaluation and Internal Auditing for FDA and ISO 13485 Compliance: Pack of Three Courses
- ISO 13485:2016 - What are the hot topics and changes?
- Supplier Management with the new Medical Device Regulation EU MDR 745/2017
- Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
- Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
