MedTech I.Q.

The Cutting Edge of Medical Technology Content, Community & Collaboration

Webinar On "Medical Device cybersecurity following latest FDA Guidance"

Event Details

Webinar On "Medical Device cybersecurity following latest FDA Guidance"

Time: November 28, 2018 from 1pm to 2pm
Location: Online
Street: 9106 Seven Locks Road
City/Town: Bethesda
Website or Map: https://www.compliancetrainin…
Phone: 1-844-216-5230
Event Type: online, /, webinar
Organized By: Sam Miller
Latest Activity: Nov 15, 2018

Export to Outlook or iCal (.ics)

Event Description

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.
Areas Covered in the Session :
  1. Cybersecurity plan
  2. Risk based analysis
  3. Hazard analysis following ISO14971
  4. Risk communication to users
  5. Required membership in information sharing groups
  6. Reporting requirements and the exceptions
Who Will Benefit:
  1. company management
  2. IT personnel
  3. Development Engineers
  4. Production Management
  5. QA/ QC personnel
  6. Software developers
About Speaker:
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. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/ non-conforming product programs.

Edwin Waldbusser 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.

Comment Wall

Comment

RSVP for Webinar On "Medical Device cybersecurity following latest FDA Guidance" to add comments!

Join MedTech I.Q.

Attending (1)

© 2024   Created by CC-Conrad Clyburn-MedForeSight.   Powered by

Badges  |  Report an Issue  |  Terms of Service