Medical Device Premarket and Post Market Cybersecurity-Online Webinar

Wednesday, Apr 12, 2017 at 10:00AM - 1:00PM
Fremont, CA

Event Details

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. This webinar will describe a program that will minimize risk to the user from cyber attacks.

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.

Objectives of the Presentation
  • What is cybersecurity
  • Current cybersecurity threats to medical devices
  • FDA's perspectives on the roles of medical device suppliers in cybersecurity management
  • Developing robust security mitigations to incorporate into your device design
  • How to maintain a compliant program
  • Cybersecurity risk analysis
  • Information sharing groups(ISAO)
  • Interfacing with network users
  • FDA conditions for not reporting cybersecurity problems
Why Should you Attend
Medical device cybersecurity has become very important to the FDA. They have issued two recent guidances on the subject, the latest in December 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 cybersecurity 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.

Who will Benefit
  • Medical device company CEOs/Presidents/Managing Directors
  • Hospital Risk Managers
  • Clinical Department Heads
  • IT security professionals
  • Engineering Manager
  • Regulatory Personnel
  • Development Engineers
  • Production Management
  • QA/QC Personnel
  • Software Developers
  • Usability engineers
  • Risk managers & Design Engineering Managers.

For Registration

Note: Use Promo code DE5YU and get 10% off on registration (Valid till APRIL 30th 2017)

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
Fremont, CA 94536

Starts April 12, 2017 at 10:00AM - 1:00PM

Add to my calendar  

Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896