Standards and Their Role in Medical Device and Patient Safety

Instructor: Lena Cordie
Product ID: 704654
  • Duration: 90 Min
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This training program will explore the relationship of standards to medical device legal requirements. It will clarify the standards development process and discuss relationship of standards to patient safety.

Why Should You Attend:

Standards provide an important source of information and guidance for medical device manufacturing, and while the content of the standards may be used by most medical device companies, the development of standards and the role they play in medical device and patient safety are less commonly understood. This session will explain what a standard is, the relationship of standards to medical device regulation/legislation, standards development and application, and how standards affect patient safety.

Learning Objectives:

  • Clarification of the standards development process
  • Understand the structure of a standard and how to read them
  • Learn how to apply standards to your organization

Areas Covered in the Webinar:

  • What is a standard?
  • Relationship of standards to medical device legal requirements
  • Standards development organizations
  • Standards development process and timeline
  • Relationship of standards to patient safety

Who Will Benefit:

  • Quality associates
  • R&D engineers
  • Marketing associates
  • Regulatory associates

Instructor Profile:

Lena Cordie has over 20 years of quality and project management experience including 10 years in project management at Target Financial Services and 11 years as director of operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.

As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on helping companies implement quality management systems, UDI solutions for labelling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies.

She is an active member of AAMI (Association for the Advancement of Medical Instrumentation) – serves as a voting member of many sterilization standards committees and co-chairs the terminology committee; ISO (International Organization for Standardization) – serves as a US representative and participates in ISO/TC 198 (ISO 17664 & ISO 11139) and ISO/TC 210 (ISO 13485 & ISO 15223) working groups; and RAPS (Regulatory Affairs Professionals Society) – serving as chairperson of the RAPS Twin Cities Chapter.

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