Medical device cybersecurity following latest FDA Guidance in 2019

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

"Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems"

A program that will be compliant to the FDA requirements

Description

The company must establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market. The cybersecurity program must be carefully planned. 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. This webinar will describe a program that will be compliant to the FDA requirements

Why should you attend :

Medical device cybersecurity has become very important to the FDA. They have recently issued two 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 active involvement with information sharing groups

Areas Covered

Cybersecurity plan, risk based analysis,hazard analysis following ISO14971, risk communication to users, required membership in information sharing groups, reporting requirements and the exceptions

Who will Benefit

  • Company management
  • IT personnel
  • Development Engineers
  • Production Management
  • QA/ QC personnel
  • Software developers
  • Cybersecurity , ISAO, risk,  

Industries who can attend

This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Edwin Waldbusser

Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. 

His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

Back to Top