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Ref : 25594
Event :ISO 14971 Hazard Analysis at Medical Device - 2017

Date :Thursday August 17th, 2017

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

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. Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing. Many new concepts are introduced.
 
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. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network. 
 
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
 
Full Details & Registration Link:
http://www.compliance4all.com/control/w_product/~product_id=501363LIVE?channel=doctorama_Aug_2017_SEO

Further information

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Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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ISO 14971 Hazard Analysis at Medical Device - 2017 Medicine - Management - Public Health - Pharmacy
hazard analysis, medical device webinars, iso 14971, process of hazard analysis, online safety trainings, electrical safety training, fda hazard analysis, regulatory 2017 trainings
Professionals, Engineer Engineering Manager Regulatory Personnel QA
100 1 --
English

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