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MDR MASTER CLASS: Workshop for the Israel MedTech Industry

February 18, 2019
Leonardo City Tower Hotel, Tel-Aviv
Keynote Speaker: Dr. Monica Tocchi, Medical Director of Meditrial

Why should I join this workshop?

The workshop “MDR MASTER CLASS” blends  Academy and Industry to offer the most modern education for Medtech and Clinical Professionals. It is designed to discover the steps for a winning transition to the new Medical Device Regulation.
The program includes exclusive content developed by Meditrial experts and is suitable for professional at any level of kwonledge (beginner to advanced professional).
Lectures allow a direct interaction with the Keynote Speaker who is an academic clinician personally involved in developing the new regulation and has hands-on experience of challenges for startups and large corportations.
Participants are exposed to a combination of trainings for regulatory and clinical skills. Learning is delived trough a dedicated portal, Meditrial Academy, where the participant can access the lecture slides, a variety of recommended readings, and take a final exam to obtain a course certification.

COURSE MAIN TOPICS

New Medical Device Regulation Training
Explore the new Medical Device Regulation (MDR) 745/2017 and learn the phylosophy of the new European System based on centralized information and much closer now to the rules already enforced by the US FDA. You will understand the key changes in the transition from the MDD to the new MDR. The knowledge gained will allow you to asses the impact for your organization and the appropriate next steps to meet the new requirements.

 

 

MDR Requirements for Clinical Investigations
Learn how to run clinical trials under the new Medical Device Regulation (MDR) 745/2017. Get ready for the evolutions that will enhance your trials and increase your success.
Discover the key changes of ISO 14155:2019 – GCP for medical devices – from Dr. Tocchi who is one of the international experts that developed this new standard. Get ready for applying the new concepts for clinical trial design and conduct, risk management, data capture and safety assessments.

SCHEDULE

February 18, 2019
Leonardo City Tower Hotel, Tel-Aviv

09:00 Registration for Workshop MDR MASTER CLASS
09:15 MDR Overview and implementation timelines, EUDAMED 101, UDI tips and tricks, new approaches for labeling and IFU
11:00 Coffee break
11:15 Postmarket program: how to steramline surveillance, PMCF, Vigilance. Select and manage the economic operators for market success

13:00 Lunch break

14:00 MDR for Clinical Trials – New MDR Rules for Clinical Investigations. What, when and how to get ready
15:45 Coffee break
16:00 New ISO 14155:2019, key changes and how they affect your trials
17:00 F2F meetings

Presenters:

Dott. Rossella Mercuri
Ing. Daniele Zago

WHO SHOULD PARTICIPATE?

Members of the Medtech Industry and Clinical Research Community who want to quickly gain a complete skillset to be successful in the new MDR era.

All professionals are welcome since easy learning using the most modern training tools (effective content, dedicated portal, app for mobile devices) combined with a one-on-one personal approach of the workshop are the core of our educational model.

The course is ideal for

  • Clinical and Biomedical Engineers
  • Manufacturers of Medical Devices
  • Medical devices designers
  • Regulatory affairs specialists
  • Quality system specialists
  • Clinical project managers
  • Clinical trial monitors

SPEAKER PROFILE
Dr. Monica Tocchi

Dr. Monica Tocchi is a physician with a specialization in cardiology and PhD in cardiovascular pathophysiology, author of multiple groundbreaking research publications.
She is medical director of Meditrial, a CRO that manages clinical trials and market approvals for some of the most innovative devices in the world. As CEO of a medical device startup company, she understands the needs and challenges of innovators.
Dr. Tocchi is an expert on European and U.S. regulations and works with the ISO (lnternational Standardization Organization) and AAMI (Association for the Advancement of Medical Instrumentation) committees to develop new regulations on clinical trials (ISO 14155) cardiac valves (ISO 5840, ISO 5910) and other medical device standards.

The course material includes:

– Personal Access to Meditrial Academy Online Training Portal
– Guidelines and Training Materials
– Meditrial MDR Pocketbook
– Meditrial Academy App free download
– Final Online Exam
– Meditrial Academy Certificate

A certificate of attendance for professional development will be given to each participant who completes the workshop.

Course Organization: Edu-Med


Sivan Gal-On
+972 52-3533646
office@edu-med.info

Registration fee

Standard Registration, Workshops: $480,38

The registration fee is payable in advance.

Bank transfer:
Top Li-Med Technology
Bank: Hapoalim
Branch: 537
Account No. 187391
Please send a reference of the transfer by email to office@edu-med.info

***Invoice will be issued and emailed separately***

Testimonials

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"The MDR pocketbook is the perfect size for an on-the-go reference. It’s efficiently and effectively organized to access the various Articles and Annexes. Mine is now highlighted, indexed, tabbed, and full of notes. I refer to it every day!"
Larry Carrier
Regulatory Affairs, Endologix, Inc.
“The Meditrial team has created a workshop, curriculum and toolset to enable small companies like ours to understand the breadth and magnitude of the impact the new MDR regulation has on our business. Over the course of one day our team was able to gain an understanding of the business segments affected, and what updates to make in order to satisfy MDR requirements. Thank you Dr. Tocchi and the Meditrial team for your efforts to support companies like ours through the MDR transition.”
Russ Sampson
PE, CTO, Ancora Heart, Inc., Santa Clara, CA 95054
"Dr. Tocchi, Thank you again for the very well organized, clear, and concise recent MDR workshop you delivered at Ancora Heart. You and your team have taken a complex subject and really made it understandable and accessible for our team. I was impressed with both the content and format of the information, and I think the modular approach you all have taken is very helpful also."
Bart Beasley
Vice President, Clinical Marketing, Ancora Heart, Inc.
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