Cybersecurity Challenges in Medical Devices: Navigating the Latest Regulatory Updates

Increasingly, medical devices have integrated wireless, Internet and network capabilities enabling the electronic transmission of personal health information.

As one of the most regulated industries, medical device manufacturers now need to comply to additional regulations to ensure their products and designs are protected from unauthorized access and tampering. The FDA has issued for comment guidance it is crafting around Cybersecurity for Medical Devices, while in 2019 the EU issued Guidance on Cybersecurity for medical devices.

Objective

Participants will have a greater understanding of the regulations and guidance regarding cybersecurity regulations in the medical device industry, including the concept of secure by design. Elements required for an effective framework will be discussed as well as the legal exposure and potential loss of business by of disregarding these guidelines. We will provide a brief overview of the benefits of leveraging a strong governance system to manage the varies global regulations.

Target Audience: This webinar is aimed at medical device engineers and developers as well as compliance officers.

Language: English

Cost: No Charge

Can't make a live session? Register now and receive a complimentary recording after the live event. For further information, please contact: KN.NAM.Marketing@sgs.com

Speakers:

Willy Fabritius
Global Head of Strategy & Business Development Information Security, SGS

Willy has a MSc in Computer Science. For more than 25 years, Willy has held management positions with organizations in the private sectors. His experience the Management Systems goes back to 1994 when he implemented an ISO 9002:1994 QMS at a Stamping Facility in Germany which got certified in less than 12 months.

He is a qualified lead auditor for a variety of standards: ISO 9001, ISO 27001, CSA-STAR, ISO 27701, ISO 22301 and has audited multiple fortune 100 organizations to these standards. Willy has worked for several global Certifications Bodies and delivered thousands of audits in APEC, Africa, Europe and the Americas.

Willy was the Global Head for Information Security, Privacy and Business Continuity for one the largest 3rd party Certification Body, before joining SGS as the Global Head for Strategy and Business Development.

Balázs Bozsik
Technical Director - MDD/MDR, SGS

With a passion for continuous improvement, Mr. Balazs Bozsik is the Technical Director for the medical audit team of SGS North America. Following his graduation as integrated mechanical engineer from BUTE in Budapest, Hungary, he gained industrial experience in manufacturing technology and design engineering in the medical (X-ray diagnostic devices), automotive, and consumer lighting industries. Prior to joining SGS, he worked for another TIC organization for over 14 years, including his roles as global MDSAP Program Manager, certification officer, product specialist focusing on active medical devices and medical software, as well as medical auditor for all major certification schemes.

Greg Jacobson
Sales Director - Medical Devices, SGS

Greg Jacobson is the Director of Sales for the medical division at SGS North America. As a senior sales and medical device professional, he contributes to strategy, recommends resourcing requirements, and improves sales processes to drive client satisfaction. Greg has many years of experience in medical devices certification sales, where in the last 10 years he was responsible for managing high-risk device accounts. He has also held other sales roles both inside and outside of the TIC Industry