Attendees should expect to learn:

• What the new Omnibus Law/FDA requirements mean for Medical Device Manufacturers
• How functional safety relates to product and patient security
• Why aligning product security to your product’s lifecycle and digital thread is the long-term formula to success

Abstract

On March 29th, 2023, FDA’s new product cybersecurity enforcement begins. December’s Omnibus Bill requires Medical Device OEMs to submit a Software Bill of Material (SBOM) and to use SBOMs to coordinate Post-Market product cybersecurity efforts. This legislation applies to all products (including legacy) with software defined components and is meant to replace the FDA’s proposed medical device cybersecurity requirements (taken from the PATCH Act).

About our speakers

David Wolf – PTC

David Wolf is a life science sales overlay and thought leader at PTC. He’s passionate about helping companies improve their product development, quality, and regulatory processes.

His focus is on using the digital thread to empower employees, reduce quality costs and shorten NPI cycle times.

PTC is a Global Leader in PLM, ALM, CAD, IoT, AR and SLM Software. They provide purpose-built solutions that scale across industries and connect business data to the digital thread.

Sean Barry – Cybellum

Sean Barry leads Cybellum’s Business Development efforts in North America. His focus is on establishing partnerships at the intersection of product security and lifecycle management.

He’s passionate about making connected products safe & secure.

Cybellum empowers product security teams to proactively manage cyber risk and compliance across their entire portfolio.