רגולציית ציוד רפואי

לוח שנה
10/24/2018 12:00 AM 10/24/2018 12:00 AM רגולציית ציוד רפואי מלון מטרופוליטן, טרומפלדור 11, ת"א, ישראל,

24

אוקטובר
2018
לתאריכים המלאים
24
אוקטובר
יום ד'

סוג אירוע

הדרכה

ענפים

מכשור ומחשוב רפואי

קוד אירוע

11538

מיקום

מלון מטרופוליטן, טרומפלדור 11, ת"א, ישראל

תגית מחיר מחיר האירוע:   300 ₪

תגית הנחה מחיר לחברי המכון:   180 ₪

5% הנחה לנרשמים בהרשמה מקוונת באמצעות אתר המכון

לבקשת מידע נוסף

European Union Medical Devices Regulations

הרחב הכל

+

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

+

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

• 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

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

13:30-14:00 Q&A

by: Mr. Marco Molinari, Business Development Manager in BSI Group Medical Device 

About the speakers

+

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

דמי הרשמה

+

180 ₪ - לחברי מכון

300 ₪ - לשאינם חברים

 

הרשמה ופרטים נוספים

+

יש לשלוח את ספח ההרשמה למרכז ללימודי יצוא וסחר בין-לאומי לפקס. 03-5142984 או בדואר אלקטרוני: yonathan@export.gov.il

לפרטים נוספים: 

המרכז ללימודי יצוא וסחר בינ"ל,

טלפון: 03-5142867/845/819/831

 

טעינה

אירוע השבוע