RAPS Texas Chapter Meeting

Assure a successful transition: ISO 13485:2016

Speaker: Susan Mecca, Senior Medical Technical Manager – Americas, Lloyd’s Register

Join us as Susan discusses how to implement and maintain ISO 13485:2016 in order to help manufacturers ensure a successful transition to the revised standard. We will share 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

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