The Need for Better Regulatory Information Management in Medical Device Manufacturing

Medical device companies face an extraordinary set of challenges today. Complex and constantly changing regulatory compliance, growing product quality requirements and the evolving landscape of digital technologies are both an opportunity and a challenge for medical device companies seeking to compete and innovate.

To navigate this environment, companies must find ways to maximize revenues and ROI by manufacturing products as efficiently and cost-effectively as possible. To serve global markets, they must develop products that comply with global regulations, adhere to each country’s submission process and meet growing customer needs — and they must do all this in a timely manner.

Not an easy task at all, especially when so many companies suffer from these common issues:

1. Regulatory groups are involved too-little and too-late in the product development process

2. Siloed systems for product-related information

3. Unsalable products due to delayed compliance renewals and changing country regulations

In this free webinar, expert speakers will discuss actionable insights on:

• Regulatory information management strategies
• Technology approach to better manage and structure internal teams, processes and data
• Preparing your organization to better navigate future regulatory and organizational changes like EU MDR, UDI and others

Speakers

Van Gresham, Partner, Kalypso

Van Gresham focuses on product development; change management; product lifecycle management (PLM) strategy; and implementation work in the life sciences, manufacturing and high-tech industries. With nearly 30 years of diverse experience, Van has been a major factor in building Kalypso’s enterprise technology practice, defining implementation strategy, methodologies and best practices.

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Caroline Byrd, Director, Commercial RA/QA, Leica Biosystems

Caroline Byrd is a Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) subject matter expert and industry proponent for product lifecycle management systems to enable efficient compliance to evolving global regulatory changes. She is currently focused on IVDR implementation at Leica Biosystems, after previously leading the MDR program for Abbott’s Medical Device Division.

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Ian Bennett, Senior Manager, Smith & Nephew

Ian Bennett is a senior manager and coach for agile principles and practices on scrum and Scaled Agile Framework (SAFe) at Smith & Nephew, with over 15 years of experience creating and managing product solutions for IBM, MIT and Smith & Nephew.

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Rich Randall, PLM Architect & Digital Innovator, Manager, Kalypso

Rich Randall is responsible for solving complex problems within organizations by crafting innovative end-to-end solutions with high-performing and diverse teams. He has over 12 years of experience working in regulated industries including medical device and defence, where he has developed product development and product lifecycle management architectures and deployed product lifecycle management solutions across the enterprise.

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