Medical Device Software and Cybersecurity

As medical devices become more and more interconnected — and the applications of medical device software grow exponentially — there is a need 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, the presenter will help attendees 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. The presenter will discuss 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.

About the presenter

Sade Sobande, lead QA/RA consultant  

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.