Medical Device Hazard Analysis Following ISO 14971 - 2017
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Website http://www.compliance4all.com/control/w_product/~product_id=501363LIVE?channel=ourglocal_Nov_2017_SE |
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Category Medical Devices, Trainings, 2017 Advanced courses, Design Control Programs, risk management classes, Online Compliance Courses, concepts of hazard analysis, FMEA Trainings
Deadline: November 07, 2017 | Date: November 08, 2017
Venue/Country: Fremont, U.S.A
Updated: 2017-09-21 15:15:53 (GMT+9)
Call For Papers - CFP
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 termsHazard Analysis Process Explanation using a TemplateExamples of Terms will be givenHazard Analysis Examples will be Covered Step by StepWho Will Benefit:EngineerEngineering ManagerRegulatory PersonnelQASpeaker 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: +1-800-447-9407Email: supportcompliance4All.com
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