12-16 October 2020 ★ VIRTUAL EVENT
Delivered in CEST Time Zone
Use VIP Code CQ20MTCHBSI to save 25% off* your pass
BSI is a trusted, world-class Notified Body and Conformity Assessment Body dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers around the world. Our services include system certification to ISO 13485, CE marking, product testing, and standardization to support your global market access goals. BSI has two Notified Bodies, one in the UK (0086) and one in the Netherlands (2797), both of which have full scope designations to the IVDR and MDR.
Talk Titles
Monday 12 October, 13:30-14:00 CEST Session: EU Medical Device Regulation, Notified Body Overview and Update from BSI Speaker: Maddalena Pinsi - Regulatory Manager, Regulatory Services - Notified Body, BSI Joined for the Q&A by Suzanne Halliday - Regulatory Director & Head of Notified Body, BSI
Tuesday 13 October, 12:15 - 12:45 CEST Roundtable with BSI: The new UKCA and future UK regulation for Medical Devices and IVDs Speaker: Jayanth Katta - Senior Regulatory Lead Notified Body, BSI
Tuesday 13 October, 13:30-14:00 CEST Notified Body Panel Discussion: EU MDR Pain Points Speaker: Jayanth Katta - Senior Regulatory Lead Notified Body, BSI
Thursday 15 October, 13:30 -13:55 CEST Session: Initial experiences of applications under the IVDR – A Notified Body's View Speaker: Erica Conway - Global Head – IVD, BSI
BRINGING THE LATEST EU MDR, IVDR AND GLOBAL MARKET REGULATORY GUIDANCE TO YOU
Join the European Commission, Competent Authorities, Notified Bodies and industry online for the answers you need to accelerate your path to compliance Get the same dedicated coverage of PMS & Vigilance, Clinical Strategies, Combination Products, Software, Law, Biocompatibility and Medical Device Regulatory Project Management from the comfort of your own seat
MEDTECH SUMMIT VIRTUAL AGENDA AT A GLANCE
Plus, an online Medical Device Regulatory Project Management training course spread across 4 days at
14:00 – 17:00, on 27-30 October.
PUT YOUR QUESTIONS DIRECTLY TO COMPETENT AUTHORITIES, NOTIFIED BODIES AND INDUSTRY INCLUDING
Gavia Taan
Unit Manager – Devices Regulatory Policy Devices Division
MHRA
Augusto Geyer
Deputy General Manager, Medical Devices Office
ANVISA, Brazil
Elaine Darcy
European Medical Device Operations Manager
NSAI
Daniele Bollati
Product Conformity Assessment /Medical Devices Expert
IMQ
Katharina Gruchenberg
Team Leader Biocompatibility and Materials of Animal Origin
TÜV SÜD Product Service GmbH
Erik Vollebregt
Partner
Axon Lawyers, The Netherlands
Alexandra Stamati
Director, Quality Assurance-PRRC Medicon Hellas SA
Maham Ansari
Director of Regulatory Affairs
Synaptive Medical, Canada
TIME'S RUNNING OUT. JOIN US TO GET YOUR QUESTIONS ANSWERED...
Connect with your fellow industry professionals online this October to benchmark, be inspired and prepare to meet the fast approaching compliance deadlines.
*Use VIP code CQ20MTCHBSI to get 25% off*
*1) Discounts not applicable to supplier/vendor/consultant/solution provider companies. Informa Connect Life Sciences will verify whether you are a supplier/vendor/consultant/solution provider when your registration is processed. 2) Discounts not to be used in conjunction with any other discount. 3) Discount not applicable to existing bookings.
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