San Francisco Bay Area Chapter: Navigating MDR/IVDR Implementation in the Wake of Brexit

2.0
RAC Credits
Wednesday, 15 January 2020 (5:30 PM) - Wednesday, 15 January 2020 (8:30 PM) Pacific Time (US & Canada)
3175 Bowers Ave, Rooms 2130/2150
Santa Clara, California, USA, 95054-3225

*Student: $15
Member: $30
Nonmember:  $40


Hosted by our partner...


*Fax/email in a completed registration form to get the student rate.

Join us for an in-depth look at the changes to global regulatory strategy in times of uncertainty. The complexity of developing new medical devices is even more challenging than ever before given the need for relabeling existing products, navigating new regulatory pathways and increased competition for Notified Bodies. 

Most companies by now have completed their gap assessments and are actively implementing changes to their product development approach to become compliant with MDR and/or IVDR. The Regulatory implications of Brexit on the new medical device and IVD regulations add another layer of complexity to a global product development strategy. 

Our speakers will share with you their stories and key learnings of how they are navigating the changes in this challenging Regulatory environment. Regulatory compliance continues to be a moving target requiring mitigation workarounds and revisions to portfolio strategies. Join us to explore how to build a global regulatory strategy that is fit for today, and for whatever tomorrow may bring. Each presentation will last approximately 30-45 minutes, followed by a panel discussion and Q&A session.

MDR/IVDR and Brexit: a notified body perspective (Jonathan Bis - BSI)

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

MDR and IVDR in the Wake of Brexit (Grant Bennett - Brandwood CKC)

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

QMS Aspects of MDR/IVDR Implementation (Alex Butler - 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 University of California Santa Cruz, 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 and RAC holders may claim two RAC recertification credits.


Featured Speakers:

Grant Bennett, chief executive officer, Brandwood CKC
Johnathon Bis, vice president, medical device solutions, BSI Group
Alex Butler, MBA, manager, medical device solutions, MasterControl


Register