Welcome!

News Feed Item

FDAnews Announces: Software and Cybersecurity Risk Management for Medical Devices, May 21-22

FALLS CHURCH Va., April 24, 2014 /PRNewswire-iReach/ -- Software and Cybersecurity Risk Management for Medical Devices:
Learn Best Practices from FDA and Industry Experts
**Presented by FDAnews and GessNet**
May 21-22, 2014Bethesda, MD
www.fdanews.com/SoftwareCybersecurity

(Photo: http://photos.prnewswire.com/prnh/20140424/78173)

This workshop, chaired by internationally renowned expert Fubin Wu and featuring three FDA experts, has been specifically designed to provide devicemakers with industry best practices to achieve compliance and effectively assure medical device software safety.

In fact, it's a once-in-a-lifetime opportunity to learn what the FDA's experts are thinking and how they expect devicemakers to manage the risks of medical devices that contain software.

The instructors will be:

  • Fubin Wu, Workshop Leader and Co-Founder of GessNet — software and consulting company specializing in medical device risk management
  • Paul Jones, Senior Systems/Software Engineer, Office of Science and Engineering Laboratories, CDRH
  • Dr. Lisa Simone, Biomedical Engineer, Office of Science and Engineering Laboratories, Office of Biometrics and Surveillance, CDRH
  • Dr. Yi Zhang, Visiting Scientist, Office of Science and Engineering Laboratory, CDRH 

In two days of intensive sessions, attendees will be brought up to date on the FDA's latest research on medical device software best practices, software risk management related standards and guidances and key success factors for effective software risk management.

Plus, in a special bonus, attendees will find out more about assurance levels, and what it will take to convince regulators, in one of seven invaluable case studies, always a popular and valuable way to learn. The seven case studies cover:
 

1) Best practices and a template for developing a risk traceability matrix

2) Best practices and a template for developing a cybersecurity risk traceability matrix

3) How to convincingly document information in a storytelling fashion for a medical device safety assurance case

4) How to convincingly document information for a medical device cybersecurity assurance case

5) How to apply techniques on identifying and connecting hazards, hazardous situations/causes using device examples

6) How to identify and connect assets, threats and vulnerabilities using device examples

7) How to identify and apply risk controls — and establish traceability of its implementation — using device examples

Spread throughout the course will be lessons in applying these key software risk management related standards and guidances to software development processes:
 

  • ISO 14971:2007 and EN ISO 14971:2012, IEC 62304 Medical Device Life Cycle Process, IEC TR 80002-1 Application of ISO 14971 for Software
     
  • FDA Guidance on Mobile Medical Applications, Cybersecurity in Medical Devices, Infusion Pump Total Product Life Cycle

During each teaching session, Mr. Wu and the FDA's experts will share techniques and best practices on how to:
 

  • Identify software related risks
     
  • Identify software risk control and mitigation measures
     
  • Assess and evaluate risk contributed/caused by software (premarket and post-market field issues)
     
  • Assure the completeness and adequacy of risk management
     
  • Communicate risk management information throughout the life of the product
  • Key success factors for effective software risk management

Special Take-Home Resource Kit:  Attendees will take home a jam-packed resource kit with more than 20 templates, checklists, case studies, guidances and supporting information. These are the tools that will help attendees effectively carry out the lessons learned over the two-day conference.
 

Attendees can expect to walk away with the following at the end of two intense days at Software and Cybersecurity Risk Management for Medical Devices:

  • Understanding of how medical device manufacturers can overcome both technical and regulatory compliance challenges
  • The resources and tools to help devicemakers succeed
  • The medical device industry's best practices
  • The FDA's latest updates on medical device software best practices

Who Will Benefit:

  • Software systems design engineers and managers
  • Quality, reliability and risk management engineers and managers
  • Project managers involved in design and development
  • Medical staff evaluating risk, safety or effectiveness
  • Quality managers
  • Regulatory affairs specialists and managers
  • Medical device app developers
  • IT systems development managers
  • Contract manufacturers
  • General/corporate counsel

Conference Details:
Software and Cybersecurity Risk Management for Medical Devices:
Learn Best Practices from FDA and Industry Experts
**Presented by FDAnews and GessNet**
May 21-22, 2014Bethesda, MD
www.fdanews.com/SoftwareCybersecurity  

Tuition: $1,797

Easy Ways to Register:
Online:      www.fdanews.com/SoftwareCybersecurity 
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Media Contact: Michelle Butler, FDAnews, 703-538-7665, [email protected]

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE FDAnews

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
DX World EXPO, LLC, a Lighthouse Point, Florida-based startup trade show producer and the creator of "DXWorldEXPO® - Digital Transformation Conference & Expo" has announced its executive management team. The team is headed by Levent Selamoglu, who has been named CEO. "Now is the time for a truly global DX event, to bring together the leading minds from the technology world in a conversation about Digital Transformation," he said in making the announcement.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of the 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to gre...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...