RAPS Member: $25
*Continental breakfast will be provided by compliments of Regulatory Compliance Associates, Inc
On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745. There is a three-year transition period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards.
Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us and learn strategies that can help your medical device company navigate the higher level of scrutiny.
Tips and Tricks to EU MDR Technical Documentation Preparation:
• How to prepare MDR documentation in accordance with Annex II of the EU MDR 2017/745
• What additional information is being requested in comparison to MDD
• Provide suggestions/tips on format and ways to address specific requirements
• Indicate what is no longer acceptable to Notified Bodies
Overview of MDR Changes:
• When legacy products need to be evaluated
• Acquisition of companies with existing products on the market
• Difference between the EU and FDA requirements concerning technical documentation
• Difference between Notified Bodies
• Transferring challenges of products from one Notified Body to another
• Changes in the regulation
• Areas of higher expectations
This event is coordinated by the RAPS Florida chapter and is intended to encourage knowledge sharing and community development. Continental breakfast will be provided by compliments of Regulatory Compliance Associates, Inc., and RAC holders may claim two RAC recertification credits.
**Parking and Check-In Instructions:
The Medtronic, Dr. Glen Nelson Surgeon Education and Training Center, is located in the Sales/Marketing Building. Attendees will want to come into the Yellow Parking Lot and drive straight back to the Orange Parking Lot. Visitor Parking Spots are located in front of the Nelson Building.
Check-In at reception. Please have Identification.
Tamas Borsai, audit manager, TÜV SÜD America
Ratinder Dhami, director of regulatory affairs at Network Partners
Local contact: Jan G. Flegeau, RAPS Florida chapter or Rozanne Shirley
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.