Featured Guests 

David Wolf

PLM Life Science Sales Specialist , PTC

David Wolf is co-chairman of the Healthcare Executive Advisory Council and a 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.

Session Track:

Thursday, May 18 11:05 AM - 11:35 AM 105

PL1123B - Improve Product Quality by Weaving Quality into the Digital Thread

Improve product quality, shorten the time from failure to fix, and reduce costs with cross-functional transparency and automated compliance built into Windchill’s Quality Management System (QMS). Part centric, pre-configured ISO processes include document control with integral training tracking, internal and supplier auditing, and a regulatory hub for submissions by geography. Highly configurable workflows for enable tracking and resolving product and process non-conformances, capturing customer feedback including customer-reported non-conformances that can drive corrective and preventive actions/ change management processes. Learn how Windchill helps to unlock your Quality processes and the latest to help you on your journey.

Session Track: ALM

Wednesday, May 17 2:50 PM - 3:20 PM 207

AL1874B - No Time to Comply: New FDA Product Security Requirements

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).

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