2019 Global Regulatory and Quality Update

Description

Collaboratively hosted by the ASQ Biomedical Division/New England Discussion Group, MassMEDIC and the RAPS Boston chapter, this annual full-day program is designed to give regulatory, quality and compliance professionals a detailed update on essential regulatory news from around the globe. 

Featured presentations will include: 

• An update on Brexit from RAPS Executive Director, Paul Brooks International Medical Device Regulators Forum (IMDRF): 
• Advancing the Use of Standards for Global Harmonization, by Dr. Gail Rodriguez, senior policy advisor, US FDA 
• An update on MDSAP from Brain Ludovico, executive director, MDSAP Regulatory Certification, NSF Health Sciences 
• The status of the EU MDR and an IVDR update by Glen Emelock, US medical operations manager, National Standards Authority of Ireland