Navigating MDR/IVDR Implementation in the Wake of Brexit (RAPS)

Changes to global regulatory strategy in times of uncertainty

Developing new medical devices is more challenging than ever before given the need to relabel existing products and navigate new regulatory pathways and increased competition for Notified Bodies.

Regulatory Affairs Professionals Society speakers will share with you their stories and key learnings of how they are navigating the changes in this challenging regulatory environment. Compliance continues to be a moving target requiring mitigation workarounds and revisions to portfolio strategies.

We will explore how to build a global regulatory strategy that is fit for today and for whatever tomorrow may bring. Each presentation will last about 30-45 minutes, followed by a panel discussion and Q&A session.

Presentations include:

MDR/IVDR and Brexit: a notified body perspective

With John Bisvice president, medical device solutions, BSI Group

  • MDR/IVDR Implementations Update
  • Impact of Brexit
  • Recommendations for smooth transitions

MDR and IVDR in the Wake of Brexit

With Grant Bennettchief executive officer, Brandwood CKC

  • Key MDR/IVDR Implementation Considerations
  • Regulatory hurdles to overcome
  • Best practices and lessons learned thus far

QMS Aspects of MDR/IVDR Implementation

With Alex Butler, MBA, manager, medical device solutions, MasterControl

  • Data Requirements to meet MDR/IVDR
  • QMS Pre-Market and Post Market Data Requirements
  • Technical File and Risk Management System Updates
  • Is your QMS up to the task?

This engagement activity is hosted by the UCSC Silicon Valley Extension and brought to you by the RAPS San Francisco Bay Area chapter. This is intended to promote networking opportunities in the local regulatory community. A light meal will be available for all attendees. A light meal will be provided.

Registration

  • Students: $15 (Please fax/email in a completed registration form to get the student rate.)
  • Members: $30
  • Nonmembers: $40

RAC holders may claim two recertification credits.

For a more in-depth exploration of this topic, sign up for Bill Kurani's UCSC Silicon Valley course, European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance, to be taught in summer 2020 in Santa Clara.

Wednesday, January 15 at 5:30pm to 8:30pm

Silicon Valley Campus
3175 Bowers Avenue, Santa Clara, CA 95054

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