Medical Device Hazard Analysis Following ISO 14971
WebcastFaculty
OVERVIEW
Medical Device Hazard Analysis Following ISO 14971 is organized by Compliance4All and would be held on Nov 08, 2017.
Who Will Benefit:
• Engineer
• Engineering Manager
• Regulatory Personnel
• QA
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
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.
Additional details will be posted as soon as they are available.
Who Will Benefit:
• Engineer
• Engineering Manager
• Regulatory Personnel
• QA
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
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.
Additional details will be posted as soon as they are available.
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Healthcare ManagementRELATED ONLINE COURSES
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