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HomeMedical Device TrainingFDA Guidance on Medical Device Cybersecurity – Preparing for the Present and Future

FDA Guidance on Medical Device Cybersecurity – Preparing for the Present and Future

Teachers
David Kane
Category:
IT & Data Integrity for Pharma/ Medical Device Training/ On-Demand Courses/
Clear
Duration: 60 minutes
On-Demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

In December of 2016, the US Food and Drug Administration (FDA) issued its second Cyber Security guidance entitled “Postmarket Management of Cybersecurity in Medical Devices.”  This document was preceded by “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” which was published in October of 2014.  The FDA – as part of the presidential Executive Order on Improving Critical Infrastructure Cybersecurity, and in recognition of the risk involved with the exploitation of networked medical devices – suggests very specific recommendations for device manufacturers to consider.   These guidelines serve a dual purpose of protecting patients (first and foremost) AND protecting your reputation as a manufacturer. With every new guidance or FDA regulatory initiative for Medical Devices, it becomes important to understand how these new information streams will affect organizations and their ability to stay compliant while driving their business. While the FDA clearly stresses the serious nature of the risks involved, it is natural to contemplate how critical it will be to start merging these guidelines in to standard business operations. With Cyber Security not being the primary driver behind the development of Medical Devices, it is also natural that the terminology, suggested practices, and path to securing medical devices may seem foreign to many. With the FDA suggesting both pre and post market focus on Cyber Security, how will companies know where to begin? This interactive 60- minute webinar will provide direction and information on the following topics…

  1. An introduction and overview of the FDA Medical Device Cyber Security Guidance
  2. Making sense of the terminology – and filtering out the noise
  3. A discussion on the projected enforceability of the guidance and those who will be looking out for program existence
  4. Aligning the technical guidance to actual business risk in your program
  5. Which comes first: Evaluating the current program or building Cyber Security into the business process?
    • How to build Cyber Security into the process from pre-development to deployment and maintenance
    • Evaluating the current program and building a roadmap to meet guidance requirements

Who Should Attend

WHO SHOULD ATTEND

This course will be useful to anyone who wants a deeper understanding of the FDA Cyber Security Guidance on Medical Devices and will have equal value for both technical and non-technical personnel. Business leaders and those with roles in compliance, development, legal or investment will all find beneficial information regarding the Cyber Security impact and practices that will be evolving in the Medical Device industry.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs. Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

David Kane
David Kane, with over 20 years in the field of technology, is the CEO of Ethical Intruder, a Pittsburgh based Cyber Security firm and focuses on Cyber Security related to software products.

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Clear
Duration: 60 minutes
On-Demand
Includes handouts

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