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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 recertification credits.This session will be worth 2 RAC credits.
Grant Bennett, chief executive officer, Brandwood CKC
John Bis, vice president, medical device solutions, BSI Group
Alex Butler, MBA, manager, medical device solutions, MasterControl
Local contact: Susan Carino, RAC, RAPS San Francisco Bay Area Chapter
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
Photo Release: By registering for this program, you acknowledge that your picture may be taken by RAPS agents and consent to the use of your name and likeness by RAPS for any RAPS use as deemed appropriate by the organization.
Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at firstname.lastname@example.org.