Texas Chapter: Understanding Key Aspects of the MDR

When:  Jul 20, 2018 from 6:00 PM to 8:00 PM

Friday, 20 July 2018
6:00-8:00 pm CDT
Emergo, a UL Company

2500 Bee Cave Road
Building One, Conference Room B120
Austin, TX 78746
+1 512 327 9997
 


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 requirements for medical device manufacturers, regardless of classification. Come join us to learn strategies that can help your device company navigate the higher level of scrutiny, including:

  • Device classification
  • Conformity assessment
  • Safety and performance requirements 
  • Technical documentation

This event is brought to you by the RAPS Texas chapter and is intended to facilitate knowledge sharing and engagement among professionals in the local regulatory community. A light meal will be available for all attendees. RAC holders can claim two RAC recertification credits.


Featured speaker: Ibim Tariah, PhD, technical director, BSI Inc.


Registration Information:
RAPS Members: $25
Nonmembers: $40

Location

2500 Bee Caves Rd Bldg B120
Austin, TX 78746-5869