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Medical Device Cybersecurity Risk Management Training
- 22
- March 2021
Monday - 10:00 AM PDT | 01:00 PM EDT
Duration: 3 hrs
This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.
Why Should You Attend:
You should attend this webinar to understand the regulatory requirements for cybersecurity and its risk management.
Learning Objectives:
- Describe the terminology and definitions related to medical device cybersecurity
- Identify the requirements for cybersecurity by design, including relevant standards, adversarial resilience analysis, remote access control, supply chain rigor, and requirements for premarket submissions in US and EU.
- Describe a proactive, risk-based approach in third-party collaboration, integrating cybersecurity-specific post market requirements, and working with researchers and organizations to identify emerging vulnerabilities and threats.
- Describe best practices for evidence capture during safety investigations that are independently reviewable, preserve information about the event (including chain of custody and tamper resistance) while avoiding privacy and surveillance concerns, and provide a mechanism for reapplication of knowledge.
- Identify mechanisms for resilience and containment, including minimizing exposures, creating secure environments for isolation and segmentation, creating visible and safe modes of failure, while preserving data integrity.
- Describe strategies for rapid, efficient cyber safety updates, such as automation and process documentation, secure update processes, stakeholder communication (including FDA), and OTS update verifications.
Areas Covered in the Webinar:
- What is cybersecurity for medical devices?
- What kind of products are affected?
- How to apply risk management for medical device?s cybersecurity?
Who Will Benefit:
- R&D Manager
- Regulatory Affairs Manager
- Product Manager
From Medical Device Manufacturing companies that manufacture electronical medical devices with software components
Instructor Profile:
Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects
Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.
More Trainings by Expert
ISO 13485:2016 - What are the hot topics and changes?
Supplier Management with the new Medical Device Regulation EU MDR 745/2017
Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
EU IVDR 2017/746 - the new EU regulation for invitro diagnostic
Refund Policy
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.
We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).
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