Webinar: Regulatory Landscape Changes Demand Digitalization in Medtech

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Big changes in the regulatory landscape are challenging Medtech companies:

• Overhauled EU regulations:  MDR & IVDR
• New 2018-2020 Strategic Priorities from the FDA in the US

Implementing and maintaining regulatory compliant processes and systems is a constant for Medtech firms; however, there’s a tremendous variation in chosen processes, procedures, tools and technology.   Looking back, there has been acceptance of this variation, across different size companies with very different medical products, business priorities and maturity levels.  Looking forward, with the changing regulatory landscape in view, there’s a clear increase in demand and payback for use of digitalization (i.e., software tools and technology) to respond to new regulatory requirements and initiatives.

In this webinar, Siemens PLM Software will highlight key regulatory changes and describe specific ways Medtech firms can respond using digitalization to both remain compliant and help balance business goals for safe, effective devices and profitability.

Speaker

James B. Thompson, Ph.D., Director, Industries, Medical Device & Pharmaceutical, Siemens PLM Software

Jim Thompson has worked in the Product Lifecycle Management (PLM) industry for 30 years, in various leadership and management positions.   Currently, at Siemens PLM Software, Jim is responsible for the global strategy for the Medical Device & Pharmaceutical industries.

Prior to Siemens, Jim worked for IBM in PLM software product development & consulting, and for GE as a mechanical engineer.    Jim received his doctorate from the University of Illinois at Urbana-Champaign, where his research focused on AI-based engineering decision making.

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