A Journey of Innovation and Quality
How PLM Can Amp up Quality
Initiatives and Boost Compliance

An FDAnews FREE Webinar • Sponsored by Axendia
Recorded April 27, 2017

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Every device you manufacture is the result of 1,000s — or more — prior decisions and processes.  And each of those decisions and processes needs to be documented. Not to mention be indexed, stored and ready for review at a moment’s notice.

From the minute your engineers have a new idea; you start down a path of potential complexity. A journey of balancing costs, quality, safety, regulatory compliance and profit. This was the case at one major medical technology company.

Innovative companies — like the one featured in the case study — are achieving accelerated device development with integrated Product Lifecycle Management (PLM) platforms. Would you like to streamline processes resulting in improved product quality and operational efficiencies?

If you have 60 minutes to spare on April 27th, we have some proven ideas on how to not only manufacture your products more efficiently — but more importantly boost product quality, increase innovation, speed time to market and improve patient safety.

PLM, properly executed, builds a culture of innovation and quality. Not just baseline quality, but enhanced quality. Patient safety quality. Pass your next FDA or EU inspection with flying colors quality. Management giving you high-fives quality. Profit boosting quality.

Join David Wolf, Program Director, Medical Device Strategy, PTC — Dave Hadfield, Senior Manager, Kalypso — Daniel Matlis, President, Axendia and Chris Hoag, Director, Global RA/QA eSystems, Stryker on April 27th from 1:30 p.m.-2:30 p.m. EDT when they’ll discuss how focusing on quality pays dividends for devicemakers.

In 60-minutes you’ll learn more about PLM and how innovative companies are using it to:

  • Accelerate product innovation — from original idea, to 510K approval to customers months or years quicker
  • Manage risk to drive the safety and quality of products and processes through QMS per ISO 13485:2016
  • Improve your measurement of quality metrics and head off problems before they start
  • Lower total quality cost, improve budgeting and accelerate profits
  • Shift your company’s focus from meeting regs to building quality into your processes
  • Jump ahead of the FDA and EU drives for quality — be a leader instead of a follower
  • Achieve a preventative manufacturing model with an agreed risk-benefit framework
  • Improve sales and reimbursement when you prove to regulatory agencies that your quality made devices improve patient outcomes

Register today and see how innovative companies using PLM are significantly business advantages.

Who Will Benefit

  • Quality affairs
  • Quality control
  • Product lifecycle managers
  • Design and manufacturing management
  • Project leaders
  • Risk managers
  • Metrics data managers
  • Regulatory affairs
  • IT professionals

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Meet Your Presenters

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David Wolf

Program Director, Medical Device Strategy, PTC

Prior to joining PTC, David worked for medical device manufacturing companies in a variety of roles. He has designed, patented and released several product lines for worldwide distribution. David has hands on expertise in product development, manufacturing, supply chain, regulatory and quality management. He was a catalyst that drove and managed the PTC Medical Device Suite and Validation Packages, which significantly reduces the implementation time and cost for mid-market companies.

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Dave Hadfield

Senior Manager, Kalypso

For the past 18 years, Dave has focused entirely in the medical device industry and has helped define the product lifecycle strategy for multiple top 20 medical device companies. Dave works with medical device clients to drive innovation, mitigate quality/safety problems and litigation risk, improve operational efficiency, reduce costs and enable compliance with regulations such as part 820 as well as ISO 13485 & 14971 standards.

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Daniel Matlis

President, Axendia

Daniel R. Matlis is founder and president of Axendia, an analyst firm providing trusted advice to Life-Science and Healthcare Executives on Business, Technology and Regulatory matters. Dan has over 25 years of experience in the Industry spanning the entire value chain. He is an active member in FDA’s Case for Quality Initiative and has presented Axendia’s research findings to industry executives and the FDA.

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Chris Hoag

Director, Global RA/QA eSystems, Stryker

Chris is currently the Director, Global RA/QA eSystems at Stryker. He has been in global RA/QA organization since 2012. Chris is currently helping lead improvements in Stryker’s global PLM processes and systems. Prior to his global role, Chris was CAPA Process Owner for Stryker’s Instruments Division. He was also part of the team that developed Stryker’s global NC-CAPA process and system. Prior to moving to CAPA, Chris led the Service Operations department responsible for both in-house and field service at Stryker Instruments.