ComplianceOnline

Medical Device Cybersecurity Following New FDA Guidance

Instructor: Edwin Waldbusser
Product ID: 705200
  • Duration: 60 Min

recorded version

$279.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: May-2017

Training CD / USB Drive

$379.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This training will discuss the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. Attendees will learn how to establish a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA.

Why Should You Attend:

Medical device cybersecurity has become very important to the FDA. They have issued two recent guidance’s on the subject; the latest in December of 2016.

FDA expects a proactive extensive risk based program to minimize risk to the user from cyber-attacks including involvement with information sharing groups. The company must establish a program where they identify, analyze and control cybersecurity risks. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to device users. A complex set of reporting requirements has been established with some exceptions.

This Medical device cybersecurity webinar will describe a program that will help you stay compliant with the FDA requirements. Additionally, it will help you in formulating a formal special hazard analysis for every risk, help with strategies with communication of risks and finally give guidance for a complex set of reporting requirements that have to be established.

Areas Covered in the Webinar:

  • Cybersecurity plan
  • Risk-based analysis
  • Hazard analysis following ISO 14971
  • Risk communication to users
  • Required membership in information sharing groups
  • Reporting requirements and the exceptions

Who Will Benefit:

  • Engineering Personnel
  • Production Management
  • QA/QC Personnel
  • Software Developers
  • Regulatory Personnel
Instructor Profile:
Edwin Waldbusser

Edwin Waldbusser
Regulatory Consultant, Med Device Advisors

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

Follow us :
Risk Management in Medical Devices Industry
FDA's Medical Device Software Regulation Strategy

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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