לחווית גלישה טובה יותר מומלץ להשתמש באחד מהדפדפנים הבאים:
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
08:30 Registration and Light Breakfast
08:45 Welcoming & Introduction
09:00-11:30 The New EU MDR: new regulations for a new operational scenario in medical device sector
• General Safety and Performance Requirements.
• Clinical & PMS: Clinical Evaluation / Investigation / PMCF / PSUR / SSCP
• Label & UDI
• European MDR transition
by: Mr. Paolo Valsecchi, Scheme Manager and Technical Expert Vascular Medical Devices, BSI Group
12:00-12:30 Coffee break
12:45-13:30 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
by: Mr. Marco Molinari, Business Development Manager in BSI Group Medical Device
Mr. Paolo Valsecchi, Scheme Manager and Technical Expert Vascular Medical Devices, BSI Group
Education: a solid technical background supported by degree in biomedical engineering and continuous training to develop technical expertise, project management and leadership skills.
Background: 10 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 December 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
180 ₪ - לחברי מכון
300 ₪ - לשאינם חברים
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