--- title: "Whitepaper: Smart Quality Management, Industry 4.0 and Quality Management Systems • Generis" description: "In order to remain competitive in the rapidly-evolving Industry 4.0 landscape, most companies will be required to make technological changes. In the medical device industry, there are a number of unique considerations this technological change presents. This whitepaper, written by Pilgrim Quality Solutions and produced by Generis, explores the impact Industry 4.0 will have on the medical device industry, and how to make the shift to ‘Quality 4.0’. It explores areas where medical device manufacturers should focus investment; the impact on product validation and regulatory and quality compliance; and how Quality Leaders can embed operational quality into risk processes that are outside of traditional QMS. View the whitepaper to explore: Industry 4.0 – What is Industry 4.0 and What is Driving it – The Smart Factory, Cyberphysical Systems, and the Internet of Things – Effect on Products and Processes Implications for the Medical Device Industry – Focus on Digital Technologies – Data Security – Investing in Change Impact on Validation, Regulatory & Quality Compliance – Validating Smart Products – FDA Guidance – Understanding the Quality Impact of the Smart Factory – Embedding Quality in the Value Chain How to Move Toward Smart Quality Management – The Need for Automated, Operational Quality Risk Management – How Quality Leaders Can Gain Organizational Support for Quality 4.0 Initiatives – Quality 4.0 Investments to Support Industry 4.0 – Strategic Objectives   Smart Quality Management, Industry 4.0 and Quality Management Systems" image: https://blog.generisgp.com/hubfs/Medical%20Device%20Stock%20image.png --- [Skip to content](https://blog.generisgp.com/blog/2017/09/25/whitepaper-smart-quality-management-industry-4-0-quality-management-systems#main-content) [![Generis Logo full Colour (Large) (1)](https://blog.generisgp.com/hs-fs/hubfs/Generis%20Logo%20full%20Colour%20(Large)%20(1).png?width=773&height=112&name=Generis%20Logo%20full%20Colour%20(Large)%20(1).png "Generis Logo full Colour (Large) (1)")](https://blog.generisgp.com/blog) - [Quality & Compliance](https://blog.generisgp.com/blog/tag/quality-compliance), - [Medical Device](https://blog.generisgp.com/blog/tag/medical-device) # Whitepaper: Smart Quality Management, Industry 4.0 and Quality Management Systems - September 25, 2017 [Generis](https://blog.generisgp.com/blog/author/generis) In order to remain competitive in the rapidly-evolving Industry 4.0 landscape, most companies will be required to make technological changes. In the medical device industry, there are a number of unique considerations this technological change presents. This [whitepaper](https://generisgp.com/wp-content/uploads/2017/09/Smart-Quality-Management-Industry-4.0-and-Quality-Management-Systems.pdf), written by [Pilgrim Quality Solutions](http://www.pilgrimquality.com/) and produced by Generis, explores the impact Industry 4.0 will have on the medical device industry, and how to make the shift to ‘Quality 4.0’. It explores areas where medical device manufacturers should focus investment; the impact on product validation and regulatory and quality compliance; and how Quality Leaders can embed operational quality into risk processes that are outside of traditional QMS. [View the whitepaper](https://generisgp.com/wp-content/uploads/2017/09/Smart-Quality-Management-Industry-4.0-and-Quality-Management-Systems.pdf) to explore: Industry 4.0 – What is Industry 4.0 and What is Driving it – The Smart Factory, Cyberphysical Systems, and the Internet of Things – Effect on Products and Processes Implications for the Medical Device Industry – Focus on Digital Technologies – Data Security – Investing in Change Impact on Validation, Regulatory & Quality Compliance – Validating Smart Products – FDA Guidance – Understanding the Quality Impact of the Smart Factory – Embedding Quality in the Value Chain How to Move Toward Smart Quality Management – The Need for Automated, Operational Quality Risk Management – How Quality Leaders Can Gain Organizational Support for Quality 4.0 Initiatives – Quality 4.0 Investments to Support Industry 4.0 – Strategic Objectives   [![](https://blog.generisgp.com/hs-fs/hubfs/Imported_Blog_Media/pilgrim-232x300.png?width=349&height=451&name=pilgrim-232x300.png)](https://generisgp.com/wp-content/uploads/2017/09/Smart-Quality-Management-Industry-4.0-and-Quality-Management-Systems.pdf) [Smart Quality Management, Industry 4.0 and Quality Management Systems](https://generisgp.com/wp-content/uploads/2017/09/Smart-Quality-Management-Industry-4.0-and-Quality-Management-Systems.pdf) ![Generis](https://blog.generisgp.com/hubfs/Square!-1.png) ## [Generis Generis is a Full-Service Organizer of World Class Business Summits.](https://blog.generisgp.com/blog/author/generis) [Visit Homepage](https://amdsummit.com) ## RELATED NEWS [![](https://blog.generisgp.com/hubfs/ASC26%20Post%20Summit%20Recap.jpg)](https://blog.generisgp.com/blog/celebrating-10-years-of-the-american-supply-chain-summit) [Supply Chain](https://blog.generisgp.com/blog/tag/supply-chain), [Summit](https://blog.generisgp.com/blog/tag/summit), [Summit Recap](https://blog.generisgp.com/blog/tag/summit-recap) ### [A Decade of Supply Chain Excellence: Recapping the 10th Annual American Supply Chain Summit](https://blog.generisgp.com/blog/celebrating-10-years-of-the-american-supply-chain-summit) Introduction The [American Supply Chain Summit](https://supplychainus.com/) celebrated a major milestone in 2026—its 10th anniversary! Over the... by Rena Wu [Learn More](https://blog.generisgp.com/blog/celebrating-10-years-of-the-american-supply-chain-summit) [![](https://blog.generisgp.com/hubfs/Email%20Banners%20(11)-Jun-22-2026-06-51-53-5530-PM.png)](https://blog.generisgp.com/blog/alok-sharan-speaker-spotlight) [Speaker Spotlight](https://blog.generisgp.com/blog/tag/speaker-spotlight), [Electronics](https://blog.generisgp.com/blog/tag/electronics) ### [Inside the Process: Alok Sharan on Quality, Yield, and Continuous Improvement \[Speaker Spotlight\]](https://blog.generisgp.com/blog/alok-sharan-speaker-spotlight) At the [American Electronics Manufacturing Summit](http://electronicssummit.com), Alok Sharan, Director of Quality Management at [Micro Systems...](https://www.mst.com/en-int/msei) by Rihana Alladina [Learn More](https://blog.generisgp.com/blog/alok-sharan-speaker-spotlight) [![](https://blog.generisgp.com/hubfs/BIO%2026%20Post-Summit%20Recap%20Blog.jpg)](https://blog.generisgp.com/blog/what-we-learned-at-the-american-biomanufacturing-summit-2026-recap-key-insights) [Pharma](https://blog.generisgp.com/blog/tag/pharma), [Manufacturing](https://blog.generisgp.com/blog/tag/manufacturing), [Biomanufacturing](https://blog.generisgp.com/blog/tag/biomanufacturing), [Summit Recap](https://blog.generisgp.com/blog/tag/summit-recap) ### [What We Learned at the American Biomanufacturing Summit: 2026 Recap & Key Insights](https://blog.generisgp.com/blog/what-we-learned-at-the-american-biomanufacturing-summit-2026-recap-key-insights) Introduction The Golden State played host to some of the sharpest minds in biopharma as the [12th annual American...](https://biomanamerica.com/) by Rena Wu [Learn More](https://blog.generisgp.com/blog/what-we-learned-at-the-american-biomanufacturing-summit-2026-recap-key-insights) [Visit Homepage](https://generisgp.com/) --- ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "Generis", "url" : "https://blog.generisgp.com/blog/author/generis" }, "dateModified" : "2023-08-03T19:57:25.898Z", "datePublished" : "2017-09-25T12:24:50.000Z", "headline" : "Whitepaper: Smart Quality Management, Industry 4.0 and Quality Management Systems • Generis", "image" : [ "https://blog.generisgp.com/hubfs/Medical%20Device%20Stock%20image.png" ], "mainEntityOfPage" : { "@id" : "https://blog.generisgp.com/blog/2017/09/25/whitepaper-smart-quality-management-industry-4-0-quality-management-systems", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://blog.generisgp.com/hubfs/Generis%20Logo.png" }, "name" : "Generis" } } ```