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Medical Device Hazard Analysis Following ISO 14971 - 2020


Date
Nov 09, 2021 - 12:00 PM
Organizer
Netzealous LLC DBA - Compliance4All
Venue
online
Location
161 Mission Falls Lane, Suite 216,

Fremont,
CA,
US,
ZIP: 94539
Phone: 18004479407

Ticket Price: $ 150.00
Overview:  
The US FDA expects that as part of a product development Design Control
Program risk management will be conducted. FDA recommends using ISO
14971 as a guide and has accepted it as a recognized standard.

Why should you Attend: 
FDA expects that as part of a product development program risk management
will be conducted. FDA recommends using ISO 14971 as a guide and has
accepted it as a recognized standard. 

Areas Covered in the Session:
Explanation of Hazard Analysis terms
Hazard Analysis Process Explanation using a Template
Examples of Terms will be given
Hazard Analysis Examples will be Covered Step by Step

Who Will Benefit:
Engineer
Engineering Manager
Regulatory Personnel
QA

Speaker Profile:
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 US and internationally 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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

Event Categories
Keywords: Educational, Health , HealthCare , healthy, training , medical




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