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:
Register today and see how innovative companies using PLM are significantly business advantages.
Who Will Benefit
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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.
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.
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.
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.