Medical Device Premarket and Post market Cyber security following the new FDA Guidances


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. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing. He now consults internationally in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed has a B.S. Mechanical En........

Overview

Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. This vulnerability increases as medical devices are increasingly connected to the Internet, hospital networks, and to other medical devices.
All medical devices carry a certain amount of risk. The FDA allows devices to be marketed when there is a reasonable assurance that the benefits to patients outweigh the risks. While the increased use of wireless technology and software in medical devices also increases the risks of potential cyber security threats, these same features also improve health care and increase the ability of health care providers to treat patients.
Addressing cyber security threats, and thus reducing information security risks, is especially challenging. Because cyber security threats cannot be completely eliminated, manufacturers, hospitals and facilities must work to manage them. There is a need to balance protecting patient safety and promoting the development of innovative technologies and improved device performance.
This webinar will describe a program that will minimize risk to the user from cyberattacks. Short description of topic.

Why should you attend this webinar?

Medical device cyber security has become very important to the FDA. They have issued two recent guidance?s on the subject; the latest in December of 2016.
FDA expects a proactive extensive risk based program to minimize risk to the user from cyber attacks including involvement with information sharing groups. The company must establish a program where they identify, analyze and control cyber security risks. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to device users. A complex set of reporting requirements has been established with some exceptions established.
This webinar will describe a program that will be compliant to the FDA requirements Describe topic importance, how this can add value to the work style.

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Webinar Id: LSHCMEW005

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Duration: 90 mins

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 $167 (Single Attendee)  $599 (Unlimited Attendee)

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