European Union Medical Devices Regulations

Calendar
10/24/2018 08:30 AM 10/24/2018 02:00 PM European Union Medical Devices Regulations מכון היצוא - Israel Export Institute, המרד, תל אביב יפו, ישראל,

24

October
2018
Full Dates
24
October
Wednesday

Type

Business Meetings

Sectors

Medical Device and HIT

Event Code

6743

Location

מכון היצוא - Israel Export Institute, המרד, תל אביב יפו, ישראל

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More Information

European Union Medical Devices Regulations

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Europe's new Medical Device Regulation (MDR) will bring substantial changes to the way medical device manufacturers bring their devices to the European market, and how they maintain compliance throughout the product's life cycle. 

Register now and stay tuned with the latest updates on the European Union Medical Devices Regulations

Agenda

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08:30 Registration…  Gathering…  Networking 

09:00-11:30 The New EU MDR: new regulations for a new operational scenario in medical device sector

  • Classification
  • General  Safety and Performance Requirements.
  • Clinical & PMS: Clinical Evaluation / Investigation / PMCF / PSUR / SSCP
  • Label & UDI
  • European MDR transition

 

11:30-12:00 Q&A

 

Mr. Diego Falletti, Scheme Manager and Technical Expert Vascular Medical Devices at BSI

12:00-12:30 Light Lunch

 

12:30-13:15 Notify Body, CE mark and ISO 13485 what is the situation?

  • Why NBs are "disappearing" (at least regarding the medical sector) and: How it affects the rest of the NBs and the MD Companies?
  • What new MDRs demand of NBs?
  • How to look for and make sure the MDC works with re-notified NB?
  • Consideration for an Effective NB selection?
  • Are all NBs equally qualified?
  • What is the NB Code of Conduct (CoC)?
  • How to review proposals from NBs? What is included in the quotes? What extra fee should be expected?
  • MDSAP quality system program?
  • Switching NBs? Why and How? NBOG?
  • Quality assurance and assessment of tech docs

13:15-13:45 Q&A

Mr. TMarco Molinari, Business Development Manager in BSI Group Medical Device   

About the speakers

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Mr. Diego Falletti, Scheme Manager and Technical Expert Vascular Medical Devices, BSI Group

Education: a solid technical background supported by first degree in Materials Science & Technology and a second degree in Mechanical Engineering. In 2015 he completed an Executive MBA at SDA Bocconi – Milan in order to expand his management skills.

Background: 15 years’ experience in medical device industries, with an entire professional background in  research & development. He held different roles mainly leading new products development and manufacturing costs reduction projects. Since January 2016 joined BSI as part of Vascular Team, and his current role is scheme manager and technical expert.

 

Mr. Marco Molinari, Business Development Manager, Medical Device – Italy & Israel

Marco Molinari is a Biomedical Engineer with a MSc Degree in Biomedical Engineering for biomaterials and Tissue engineering and BSc in Biomedical engineering. He has 6 years of experience in the Healthcare industry covering several job positions such as research, account management, business development, sales & marketing. He worked at Miami Medical Center and Tissue bank and published 2 papers  as author and co-author.  He has a Master in Sales & Marketing Management at Bocconi Business School and currently he work as Business Development Manager in BSI Group Medical Device   

**The seminar will be presented in English

 

 

 

Cost

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180 ₪ -IEI MEMBERS ,

300 ₪ - Non Members

Registration

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For Registration Click here

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