Medical Device Hazard Analysis Following ISO 14971

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Overview:

In this webinar we will explain in detail the process of conducting a hazard analysis. The confusing terms "hazard", hazardous situation", "harm", "causative event", "ALARP", "risk index", "benefit/ risk ratio", and "residual risk" will be explained. We will go step by step through a template for risk analysis so that the process is clear. Examples of hazards and hazardous situations will be discussed. How to deal with residual risk will be discussed.

Areas Covered in the Session :

Explanation of Hazard Analysis terms: hazard, hazardous situation, harm, risk explanation of the hazard analysis process using a template examples of terms will be given hazard analysis examples will be covered step by step.

Speaker:

Ed is Keynote Speaker at ComplianceKey. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices.

Contact Info :
Compliancekey
https://www.compliancekey.us
Email : support@compliancekey.us
Phone :+1 717-208-8666