Texas Chapter: Implementing ISO 13485:2016

When:  Aug 17, 2018 from 6:30 PM to 8:30 PM

Friday, 17 August 2018
6:30-8:30 pm CDT
Emergo, a UL Company
2500 Bee Cave Road
Building One, Conference Room B120
Austin, TX 78746
+1 512 327 9997

ISO 13485 is an internationally agreed upon standard that outlines the requirements for a quality management system (QMS) specific to the medical devices industry. The primary objective of the standard is to facilitate harmonized medical device requirements, and compliance with ISO 13485 is often recognized as the first step in achieving compliance with European regulatory requirements. The RAPS Texas chapter invites you to come engage with your colleagues and learn how to navigate the March 2016 revisions to the standard.

Learn how to implement and maintain ISO 13485:2016 to help manufacturers ensure a successful transition to the revised standard. Susan Mecca will share the key learnings, main areas of focus, tips for the transition process and an overview of how to maintain an effective management system in accordance with ISO 13485:2016, including:

  • Software identification & validation
  • Regulatory Authority communication
  • Identification of critical supplier & components
  • Maintaining technical files
  • Risk Management

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:
Susan Mecca, technical manager, Lloyd’s Register, Medical Device Sector

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


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