RAPS Texas Chapter: ISO 13485:2016 Update – An Overview of the Changes

When:  Jul 28, 2016 from 6:00 PM to 8:00 PM (ET)

28 July 2016
6:00–8:00 pm
Emergo Group Headquarters
Austin

Join your regulatory colleagues from across Texas for an evening of networking and an expert presentation on ISO 13485:2016. This meeting is sponsored by the RAPS Texas Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory and quality professionals.

This session will cover the key changes from ISO 13485:2003 to ISO 13485:2016 and will help organizations better understand the differences between the old and new standard and how to address possible shortfalls.

Areas of focus will include:

  • Risk management
  • Design and development
  • Purchasing and suppliers
  • Production and service provision/validation

The presentation will provide answers to frequently asked questions, including:

  • What are some changes in the new standard that may not have been considered in the past?
  • What are the biggest obstacles?
  • What are some of the implications for suppliers to manufacturers under the new standard? 

Free parking is available onsite and light refreshments will be provided for all attendees. Those who hold the RAC may claim 1.5 RAC recertification credits.

Date/Time:                 
Thursday, 28 July 2016
6:00–6:30 pm     Registration, Networking and Refreshments
6:30–8:00 pm     Speaker Presentations and Q/A Session

Location:                    
Emergo Group Headquarters           
816 Congress Avenue
Third Floor, Longhorn Room
Austin, TX 78701

Get directions online or call +1 512 327 9997

Registration:
Advance Registration (prior to 22 July):
RAPS members: $30                         Nonmembers: $45

Registration (on or after 22 July):
RAPS members: $40                         Nonmembers: $55

Speaker:
Susan Mecca is the technical manager of medical devices for LRQA in North America and an experienced QMS lead assessor with qualifications in ISO 13485, CMDCAS, IVD and MDD CE marking approvals.

Local Contact:
Trilo Das, chair, RAPS Texas Chapter

RAPS Contact: 
Wesley Carr, senior program manager, chapter and account relations, RAPS