"The Role of Cybersecurity in Medical Devices" presented by Brijesh Patel & hosted by ASQ Silican Valley Section
Scheduled
The Role of Cybersecurity in Medical Devices
Presented by Brijesh Patel
Hosted by ASQ Silicon Valley Section
Date: April 20, 2022
Starts: 6:45 PM Pacific Standard Time
1. Presentation Synopsis: As the world accelerates towards a hybrid work environment where data needs to be shared real-time within Medical Facilities, Regulators and scientific bodies, there are challenges that we must address to ensure the use of the medical device and it's accessories is safe in its intended environment. What does it mean to risk management, manufacturing controls, procurement requirements and software limitations going all the way back to design requirements. While SaMD is talked about a lot, we also need to pay much closer attention to SiMD as regulations catch up to them in global markets.
2. Presenter Bio: An Intuitive, performance-based, and detail-oriented professional, offering comprehensive experience in business process optimization for quality assurance, data warehouse operations, data architecture, and business intelligence reporting across various settings. A resourceful problem solver with the ability to conceptualize cost-effective solutions to challenging situations. An efficient leader and team builder with outstanding communication, negotiation, and organizational skills. A strategic thinker, with a reputation for delivering high-quality work on time and managing a broad range of responsibilities. A Quality leader with BSE in Biomedical Engineering with minors in Mathematics and Material Science & Engineering. An ASQ CQE, Master Project Manager (MPM) from AAPM, and Lead Auditor certification from BSI for ISO 9001, 13485, 14001 and 45001.
zoom link: https://us06web.zoom.us/j/87870237635?pwd=MG4wZkJhbzhBRzZYZk9BNENmUGxIUT09
password - 026610, though it should not be needed.
Thank you,
Vern Saini
Presented by Brijesh Patel
Hosted by ASQ Silicon Valley Section
Date: April 20, 2022
Starts: 6:45 PM Pacific Standard Time
6:35-6:45 call in
6:45-6:50 welcome from section chair, Dr. Sunil Roy
6:50-8:10 introduction to Brijesh Patel by Daisy Nini, section programs chair, Presentation, Q&A.
1. Presentation Synopsis: As the world accelerates towards a hybrid work environment where data needs to be shared real-time within Medical Facilities, Regulators and scientific bodies, there are challenges that we must address to ensure the use of the medical device and it's accessories is safe in its intended environment. What does it mean to risk management, manufacturing controls, procurement requirements and software limitations going all the way back to design requirements. While SaMD is talked about a lot, we also need to pay much closer attention to SiMD as regulations catch up to them in global markets.
2. Presenter Bio: An Intuitive, performance-based, and detail-oriented professional, offering comprehensive experience in business process optimization for quality assurance, data warehouse operations, data architecture, and business intelligence reporting across various settings. A resourceful problem solver with the ability to conceptualize cost-effective solutions to challenging situations. An efficient leader and team builder with outstanding communication, negotiation, and organizational skills. A strategic thinker, with a reputation for delivering high-quality work on time and managing a broad range of responsibilities. A Quality leader with BSE in Biomedical Engineering with minors in Mathematics and Material Science & Engineering. An ASQ CQE, Master Project Manager (MPM) from AAPM, and Lead Auditor certification from BSI for ISO 9001, 13485, 14001 and 45001.
zoom link: https://us06web.zoom.us/j/87870237635?pwd=MG4wZkJhbzhBRzZYZk9BNENmUGxIUT09
password - 026610, though it should not be needed.
Thank you,
Vern Saini
News
San Francisco Section
04/21/2022 12:01am CDT
