ASQ New England Discussion Group (NEDG) Presents:
In Vitro Diagnostic Medical Device Regulation (IVDR)
June 12, 2024, 8:30 AM-5:00 PM
IVDR 2017/746 – ARE YOU READY?
The EU has prepared for IVDR for almost 2 years now. Many of your IVD colleagues say they still are not ready or prepared. Are you?
This full day seminar will provide an in-depth look at the key regulatory aspects along with QMS implementation of the European In Vitro Diagnostic Medical Devices Regulations (IVDR) 2017/746. It will be of value to anyone working in the In Vitro Medical Device community and anyone marketing or planning to market IVD’s in Europe. The seminar will focus on implementation and participants will receive certification of completion, course materials along with a variety of procedure templates and checklists.
· Introduction to EU IVDR - Overview of EU IVDR: Purpose, Scope, and Objectives, Key Changes from IVDD to IVDR, Key Dates for IVDR Implementation
· Regulatory Framework - Structure of the EU IVDR: Requirements and Annexes, Classification of In Vitro Diagnostic Devices (IVDs)
· Pre-Market Requirements - Conformity Assessment Procedures, Technical Documentation Requirements
· Post-Market Requirements - Post-Market Surveillance and Vigilance, Clinical Evaluation and Performance Studies
To Register: go to https://app.memberplanet.com/#/event/asqbiomedicaldivisioncommittee/ivdr2017746seminar
Or scan the QR code below:
Date: June 12, 2024, 8:30 AM – 5:00 PM (Registration – 8:30-9:00 AM)
Buffet lunch, drinks and breaks included.
NEDG is offering this course at a discounted rate:
· Registration Fee - $250.00
Location:
Waltham Woods Conference Center
860 Winter Street
Waltham, MA 02451
Send your questions to: Beth Kelly, Beth@Kellyqc.com or Tim Barash, t.barash@comcast.net
Presenter: Nicohl Asher - Benten Creative, Inc.
Nicohl is president of Benten Creative, Inc. She has over 25 years of experience in the medical device and pharmaceutical industry including working for a leading Notified Body as a lead auditor for ISO 13485, MDD 93/42/EEC, INMETRO, and MDSAP and most recently was a certification decision maker for ISO 13485 and MDD. She also assisted in implementation of MDR 2017/745 and IVDR 2017/746 including training of auditors. Her expertise lies in global regulatory compliance, regulatory strategy and quality system implementation. She has provided training and implemented quality and regulatory systems for manufacturer’s transitioning to MDR and IVDR worldwide.
Working agenda
