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Medical Device Hazard Analysis Following ISO 14971 - 2017

Event Details

Medical Device Hazard Analysis Following ISO 14971 - 2017

Time: November 8, 2017 from 12pm to 1pm
Location: Online
Street: 161 Mission Falls Lane, Suite 216
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: 18004479407
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Sep 20, 2017

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Event Description

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: support@compliance4All.com

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