|By PR Newswire||
|April 24, 2014 05:07 PM EDT||
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, 2014 – Bethesda, MD
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
Software and Cybersecurity Risk Management for Medical Devices:
Learn Best Practices from FDA and Industry Experts
**Presented by FDAnews and GessNet**
May 21-22, 2014 – Bethesda, MD
Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600
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
Digital transformation is too big and important for our future success to not understand the rules that apply to it. The first three rules for winning in this age of hyper-digital transformation are: Advantages in speed, analytics and operational tempos must be captured by implementing an optimized information logistics system (OILS) Real-time operational tempos (IT, people and business processes) must be achieved Businesses that can "analyze data and act and with speed" will dominate those t...
Sep. 26, 2016 04:30 AM EDT Reads: 983
SYS-CON Events announced today that Roundee / LinearHub will exhibit at the WebRTC Summit at @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LinearHub provides Roundee Service, a smart platform for enterprise video conferencing with enhanced features such as automatic recording and transcription service. Slack users can integrate Roundee to their team via Slack’s App Directory, and '/roundee' command lets your video conference ...
Sep. 26, 2016 04:30 AM EDT Reads: 1,411
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
Sep. 26, 2016 03:15 AM EDT Reads: 1,079
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Sep. 26, 2016 03:00 AM EDT Reads: 1,756
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service. In his session at 19th Cloud Exp...
Sep. 26, 2016 03:00 AM EDT Reads: 938
SYS-CON Events announced today that Secure Channels will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. The bedrock of Secure Channels Technology is a uniquely modified and enhanced process based on superencipherment. Superencipherment is the process of encrypting an already encrypted message one or more times, either using the same or a different algorithm.
Sep. 26, 2016 02:45 AM EDT Reads: 1,550
While DevOps promises a better and tighter integration among an organization’s development and operation teams and transforms an application life cycle into a continual deployment, Chef and Azure together provides a speedy, cost-effective and highly scalable vehicle for realizing the business values of this transformation. In his session at @DevOpsSummit at 19th Cloud Expo, Yung Chou, a Technology Evangelist at Microsoft, will present a unique opportunity to witness how Chef and Azure work tog...
Sep. 26, 2016 01:45 AM EDT Reads: 1,670
SYS-CON Events announced today that Numerex Corp, a leading provider of managed enterprise solutions enabling the Internet of Things (IoT), will exhibit at the 19th International Cloud Expo | @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Numerex Corp. (NASDAQ:NMRX) is a leading provider of managed enterprise solutions enabling the Internet of Things (IoT). The Company's solutions produce new revenue streams or create operating...
Sep. 26, 2016 01:00 AM EDT Reads: 1,958
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business in 2016. However, IoT is far more complex than most firms expected. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, a renowned visionary and thought leader, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology and business models to adopt and leverage IoT. He will drill down to the components in this fra...
Sep. 26, 2016 01:00 AM EDT Reads: 1,622
I'm a lonely sensor. I spend all day telling the world how I'm feeling, but none of the other sensors seem to care. I want to be connected. I want to build relationships with other sensors to be more useful for my human. I want my human to understand that when my friends next door are too hot for a while, I'll soon be flaming. And when all my friends go outside without me, I may be left behind. Don't just log my data; use the relationship graph. In his session at @ThingsExpo, Ryan Boyd, Engi...
Sep. 26, 2016 12:30 AM EDT Reads: 1,248
IoT is fundamentally transforming the auto industry, turning the vehicle into a hub for connected services, including safety, infotainment and usage-based insurance. Auto manufacturers – and businesses across all verticals – have built an entire ecosystem around the Connected Car, creating new customer touch points and revenue streams. In his session at @ThingsExpo, Macario Namie, Head of IoT Strategy at Cisco Jasper, will share real-world examples of how IoT transforms the car from a static p...
Sep. 26, 2016 12:30 AM EDT Reads: 1,543
SYS-CON Events announced today that Pulzze Systems will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Pulzze Systems, Inc. provides infrastructure products for the Internet of Things to enable any connected device and system to carry out matched operations without programming. For more information, visit http://www.pulzzesystems.com.
Sep. 26, 2016 12:15 AM EDT Reads: 1,823
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...
Sep. 25, 2016 10:45 PM EDT Reads: 1,585
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Sep. 25, 2016 10:45 PM EDT Reads: 4,416
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, will discuss the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports. The session will include a working demo and a technical d...
Sep. 25, 2016 10:00 PM EDT Reads: 1,703