Overview
The importance of Cybersecurity for Medical Devices
As medical devices become more and more interconnected — and the applications of medical device software grow exponentially — it is imperative to ensure that these devices, when placed on the market, are safe and effective and remain in this state throughout their lifetime.
In this webinar, you will acquire knowledge and develop a greater understanding of the regulatory requirements that must be complied with when placing medical device software on the market, particularly as it pertains to cybersecurity.
You will also learn about critical standards and share practical guidance in order to equip manufacturers with the information required to comply with the latest regulatory requirements and best practices.
Course Description & Learning Outcomes
As technology continues to transform the healthcare industry and cyber threats continue to evolve, there is a need for secure medical devices. This webinar provides an introduction to medical device software development and cybersecurity. This live webinar will cover:
- overview of the software development lifecycle
- overview of medical device cybersecurity
- medical device software cybersecurity requirements in the USA and EU
- cybersecurity testing
Learning outcomes:
· Understand fundamental principles of cybersecurity
· Understand the cybersecurity requirements for medical device software in the USA and EU
· Know the key legislation and standards required for medical device software compliance in the USA and EU
· Be aware of the cybersecurity submission documentation requirements
Recommended Prerequisites
Personnel from the followings job function is encourage to attend:
Software developer
Regulatory affairs
Management representatives
Regulatory Compliance
Quality Assurance
Pre-course instructions
Please register in the link below:
https://www.emergobyul.com/events/medical-device-software-and-cybersecurity#
An email instruction on how to dial in described below will be send to your registered email shortly.
Hi there, Thank you for registering for our upcoming live webinar: Title: Medical Device Software and Cybersecurity Date and Time: Tuesday, May, 14th, 2024 | 9:00 AM (Austin, Texas) -> 14th May, 2024 / 10:00pm Singapore time.
Your unique attendee link: https://global.gotowebinar.com/join/1830821439020964192/562663123
Please contact us at [email protected] if you have specific questions that you'd like our presenters to address during the online event, or if you have any questions about the webinar.
You can save the date and time in your calendar by clicking the link below. This will also save your unique attendee link.
Schedule
Date: 14 May 2024, Tuesday
Time: 10:00 PM - 11:00 PM (GMT +8:00) Kuala Lumpur, Singapore
Location: Online
Pricing
Course fees: Free
Speakers
Trainer's Profile:
Sade Sobande, Lead QA/RA consultant , EmergobyUL
Sade Sobande is an RAC-Devices accredited regulatory affairs professional with over 13 years of experience in the medical device industry. Sobande has a BEng in chemical engineering from the University of Manchester, UK, and an MSc in biochemical engineering from University College London, UK. She is passionate about regulatory strategy and submissions and ensuring customers get their products to market in the safest and most efficient manner. She specializes in regulatory strategy and submissions for medical device software. Her expertise includes international regulatory compliance for class I-III CE marked devices; class II-IV MDLs for Health Canada; compilation of FDA 510(k)s; and regulatory submissions/registrations in MENA and APAC territories.
Trainer's Profile:
Loh, Evangeline, Vice President - Regulatory Affairs, EmergobyUL
Evangeline Loh is located in the United States and holds one of the most senior positions in the Emergo consulting group with over 18 years of global regulatory experience. Her background includes European market access and compliance, global regulatory affairs requirements, global vigilance, and global regulatory strategy. As the Global Regulatory Manager, Evangeline manages EMERGO’s in-country representation services for manufacturer EU Authorized Representative, US Agent, Australian Sponsor support, and oversees global vigilance activities for these clients. She also supervises a team of international consultants and reviews dozens of device submissions and clinical evaluation reports each year.
Trainer's Profile:
Tobias Gross, Senior Software Engineer, Method Park, by UL Solutions
Tobias Groß is a senior software engineer for cybersecurity in the field of automotive and medical. Tobias has an BSc in Computer Science from the Nuremberg Institute of Technology, Germany, and an MSc in Computer Science from Friedrich-Alexander University Erlangen-Nuremberg, Germany. He got his PhD from the IT Security Infrastructure Lab of Friedrich-Alexander University Erlangen-Nuremberg. There he published in the fields of disk encryption, file system forensics, and fuzzy testing.
Trainer's Profile:
Sebastian Hammel, Software Engineering Manager , Method Park, By UL Solutions
Sebastian Hammel is a Software Engineering Manager with over 15 years experience in medical device development. Sebastian holds a Diploma (Dipl.-Ing.) in mechatronics engineering from Baden-Wuerttemberg Cooperative State University (DHBW), Germany. Sebastian is passionate about development of active medical devices in accordance with the applicable standards in a safe and most efficient way. He specializes in the development and verification of active implantable medical devices. His expertise includes the application of standards for active medical devices e.g. IEC 62304 and IEC 60601-series and the efficient way of implementing and documenting them throughout the development process.
